EXHIBIT Frerrt: edieall?rtl Te: Ct}: Nu'estll?v'lediealr?t?rl?te Dela: resist ts?hle:s8?rne edieatt?ei'ts file-la: Sent: 9i1?l201312242:13 PM Subject: Re: internal diseusslen en eemptaints with Hi Laura. 122- The repert was aetualy frem an ESE, Alan Adan?rs whe was at the user taeility perien'ning an inserviee when he everheard eusterners talking aeeLrt eessihle intestines and twe deaths. elan indietrted that the eustemer was very interested in the elevater channel. There were several scenes and the enly ens he was the TJF-?te?v ne serial number previzted. Alan was net el'tieially interrned aheut the adverse events. ti'tt'hen we teliewed us with the user taei'ty. they denied the et? any adverse events and did net previde sgeeifie serial number. He ether similar eernplaints with this repert. Thanks. Bennie t3 Trbera Superviser. Hegulatery Attairs FtNEtA?Fteg Affairs It'- Dual Assurance Olympus America Ine. 24MB- Hingweed even use San Jese, CA 95131 .I. II.- I.I I I.-I.I I I I - Farr: {403} 9355031 eenniej Lberarmety n1pus.eem This e?mail and any allaehmerts may eentain preprietary and privileged intermatien ter the use et the designated recipients named aeeve. r-?tny unaLlherieed review. use, disetesure er distributien is prehibited- If yeu are net the interded reeipieni. grease eentaet the sender by reply email and destrey ail eeples et the enginal message. [?Leura Stermsn-??f?lta??l 3 ?9:?3:35 slut-"Dear Katherine and I[Jennie - Teday. a green at us {Dave Elartew. Mary ruin Dresneeit, myseh' liaisel'rsl err-r Laura 1' fr Kalhgr'm-e Bunnie .3: gum, Sir-11.31 Hazutumi FuI-rud: thin-NEON Ivlchituni ~'r?ers hieIH-El'hterie: Te shitre Date Dart??E?t? {and AM Sal-.ject hie-met dieeussisn err reg-recs eernnleints with Dear Katherine and Bennie - Teday, a grain et us {Dave Eariew. Mary Ann Dresneeir. myself liaisensl were debriet?ed en a meeting yesterday at LPMC te review, an'iengst ether eusirwss matters. UF?hliC's interest in t'l'ls-eussmg their guestiens en et the Tee?e1sev. We are currently it the presses ei a setting up a meeting. and members at Ed may he inveived in this meeting. Right new. 1 am leetring in review all such similar eernplaints. Here is what I see and please advise me it there is any ether BLT-Hughes sitt'tilar cemplaints. Mass .- Request: [in AdWatch. there is CEDtS?EJ-Udatrlt trem Lthless. which is a new centpleint - epened August 23- Please ensue that tree are werlting with Maryihnn Dreemck en this cernpla?nt inuestlgatien. Please ensure that an ESE er ether tech representative is dispatched te this acceunt te review reprecessing practices as seen as pessihle - Duestlen: There was a similar cen'pLaint eartier in the year irem this same aeceunt: C2?t The repett. irere a sales rep. was infectiens enct twe deaths esseciat ed with the TJF-Ctta?v, ti'uhat is interesting aheut this cernplaint its that when we centacted the they deried t "e cen'plalnt- I lilte in see if there is anything tree can add te eur ur?cierstanding ef this cerrplaint that is net remained in AdWalch Carnell E22111 433 59 - It appears that this facility was net pie-clearing. lealt testing and pressuring scepe hefere SliJTttEtgil'tg in water: additintta?yr net using MW cleanitg adapter, ner using ceneel suctien cleaning adapter. else. there was physical damage - heles tn channel. tern bending section. Three Hhers 1- I am net se interested In this centplaint. The EEG discet'ered tereign material behind the elevater wire channel titling an lit-service. E55 perterrned in-sertiice training en reprecessing. The nits SWINE RegulateerIinicat Attairs 5- Quality Assurance DIyrnpus Gerperatien ef the Americas 35GB Cerperate Center Vallei FA 131334- ELY-Hughes EXHIBIT De Eerpi?el I. I .L Te: Sent: Eit?ztlt? PM Subject: Fte: Fw: Al Letter Leura, When we preytde cusiemet wih a new scene is there any training presided regarding reprecessing? Weild it be decurnented? 1.i'tihich grerqzi wele be respensible? Is there semeene else I ceuld direct these questiens te. Denny She eire Diecter. Retailer Ulymeus Gerperetien et the Americas Medical Systems Greer: 240D Ringweed Ave. San Jese. CA 9513t E?Leura ?ts-3:06 - Thentr yeuter this internistieh. es welles the cepy et the ter a similar LUI iipie int it em Leure Stermsi??i?erp?el tic-Mine Tub-em'We-st h'tediceL'DA'??m. l'tenny ilc: Hazufumi Heemi Ethernbecht H?r?ere??l?l??i Date. Re: Fw: Letter Cennie - Thentt yeu ier tlis intermetlen. es well as the ceey et the MDR fer similar trem UMASE. I suggest that yeu Stigetrt Dirune when we reach eut teday te GMSC te metre them aware ei this At request trem the FDA. Angeli-re Hunsel: has been weriring with ShigeI-ri en the cempiaints in EU: see attached- [ettechment "Re_ Atedeml" deleted by Denny ShapireiHDiCerpIDel] else. I am site that yen will emphasize that ece is set yer in discussien with LPMC en their nuesriens en the and an unidentired ELIE rnedet. Maryann will preside her netes as seen as pessiele. but it is net unreasenab?e that we sheutd centempiating seine additienal testing in address inquiries. Fer example. I irnew that tlwy are interested in the ef?cacy et Eidetr GPA against litebsietla- Denny - As per eur cenyersetien earlier teday, I suggest that we establish a team apprcach fer addressing tl'iese reprecessing guestiens, whether trem FDA er lean adwse that Meryenn and Dante be part etthis learn. I am that we get tegether as a grerp in identity actiens, required detaitest reperts, and necessary time deadlines. Thanks Laura Stern?s UR, Heguteterinltnical e?airs Duality Assuranse Olympus Eereeratien et the Americas 35m] Eerenrate Perteway lCenter Valley PA 151334 lauraslemts?eiymp us.cem ?L?r?J-Iughcs tittft silt]? I Cennie TuhetemtiElH Film 3 t2: t?zee Ph?tn-Slee wil dd. Altaehed is the list pt asseeiated with the Mir. Hepen Number These at en Cennie Te Leta: Sternusr'?il?elp?mgl?el EL: Dee-e LII-endsr Mil"! Ian" Hisae Taberipeeiympus?eiympus. Elet}: 12:12 PH Gutiect Le't'ler Sure will de- Attached is the list pt eerrplaints asseeiated with the Mir Fte pert Hunber- These are eernpleints repmeessieg eeneerns. I have all the eernplehts pulled put ter redew. Fultude-san ls travel'ng teday. se I am eepying Mr. Tape and Mr. Muriel-ante in this e-mall- hiUhllt-iElit MODEL endoscope teen-seems} Tie-1ee= I Tie-e1sev_? ems: i e_r_u_lse_ 30.10511?- DMEC 3U OMSE cages?sleelese TiF-etsee empeer-sms-ee?s peels-sJ-eeteae unmade {it'll-195 TJF -d1eeu _c1e13-sJ-ee1451 ]C?l313-5J-Ettil?33 Tit-lepu; Thanks. Best Regards. Eennie Tut-era Stlpewtser. Regulaterjr Afteirs Affairs ?ual Assurance Ulympus Arreriea Ine. Ftingwepd Avenue San Jese, CA 95131 - - - - - I - F?a. h?u-?l I.- I I r-rr-Fes: [403] ess-seet eennieJLtlerelQeri-museem CONFIDENTIALITY NOTICE: This e-rneil eernmmieetlen end eng.I attachments men.r eenteln preprletew end privileged lnterrnetlen fer the use designated recipients named Any unallherized review, use, dlselesure er distnbutlen ls prehipited. It yeu are net the lnterded reeiptentl please eentaet the eerder by reply emell and destiny ell eeples et the englnal message. BLT-Hughes eesse 1e I Laure [$22324 attain-Dear Con-plairn Team - Please process this AI as per our practice- suggest that we transmit this F: .1 Etoimsit-lilttCor ?ail-l T: amuel?uber: twessii'eflool?a??m ?uent Echantlaach'Htil'i'?ui Eta-as this ?rm Dlos Emma Hastiuroi rule {$123 Latins Dear Complaint Team Please process this ail as per our practice. suggest that we transmit this all letter today to DMSC as we have eslensite questions that require till?BC smport- I also suggest the following - a video oonferenoe with to discuss and resists question's end resporees: establish milestones for providing dratl responses. Please also let me know how I can help. I suggest that we meet this week with Mr. Yatae and Mr. Merlyerna to discuss this el letter. Thank you Laura Storms RegulatoryriCinical Attairs a Quality Assurance Dlumpes Corporation at the Americas 350D Corporate Parkway Center PA ?lB?Sri Iaura.slonns@olurmus.corn Fem-strolled lug.- Laura on oe- I1 l2 all rum: Isl-units. Erratal s?r?tt?Le-rais?idahhsgoee Ta: "Laura Stem-ts. {La ura?toim?elympuseoml' slauro?tarmsl?olempus corn:- ile: *Lewls. Gnu-seal DE wiry-stalwarts Date 9591 1:313 11 :EiEi alt-1 Eutjact Letter Hello Ms. Etorms. Attached is the additional intormatien letter I referenced today during our tonuersation. Please contact me it you have any questions or concerns. Best regards, Coastal Coastal Lewis. BA, ital Nurse Consultant food and Drug Administration Center for Devices and Radiological Health tili'iice ol' Suruei lance and Biometrics Division ni Pastmaritet Sunreillance Product Evaluation Branch 1 3133 BLT-Hughes @3352 ll [attachment ?Olym pus scope.Al.9.16.13.pdf" deleted by Connie Tubera/West/Medical/OAI] OLY?Hughes 003 52 12 EXHIBIT 1., pl -2: at?? Frein: Da veal Te: EC: Sent: meaete 4:11:25 PM Subhct: Re: Cernel pesttive cutlures Attachments: h'licrechem lab test - Acecidc vs Aldahel vs Eldest GPA agairst drug resistant lvlicrechem test - Acacide vs Aldaheld its Bide: DP against drug-resistant ergarisn'is in Here are the twe studies that Mary Ann ceenzlinated with lv'licrechent as a fellew up Ie the reperts lrern UPMC regarding dii?cuity in eliminating varietae ntulIi-rlrug resistant erganisrns trern their duedenescepes. FQMSE aereed te reimburse es ter these studies. (em I cerrect Mary sent} The first study shews that cur preducts [seaside a eldahell as well as sea {teed by LFMC and many ether acceunts] kill these "srperhugs" when they are in suspensien. The secend study shews that these same l-LDs Itill these same erganisms when they have been inectlated and dried er'te sectiens et duedenescepe bicpsy channel material. The nerd step weuld he te lneculate Intact duedenescepes. dtsInlect and culture them. Hewevcr. we are still discussing whether we slieuld talte this step. since it is my epinien eased en these tests and my limited understanding ef increlsrelegy that supereugs are net everly resistant te disinfectants just arrtieietlcs, Theretere, geing further with scepa testing may act be necessary. We are new with Marketing whether we sheuld write a generic Dear letter en the tepic pt steerhugs end else real-re the attached decunents available te eu' custenters. marched ?le: Miner-Java itch res-r - Acacitle rs sac-lava izr {'rn?cs? ?amm?m- ?Harhiqy?h? :1 my. My; AIL-19L. dE t's' Artfully}! 1-3 l? valet {rye-True: thing rh?mitvirsiprff} Best Regards. David David E. Eartew, Vice President - Technelegy Assessmert a Clinical Affairs Medical Systems Greup Olympus America Inc. asee lIlertelerelrs. Parkway Center ?v'alley, F'rl'l. l?Laura [16:25:21 F'M-ul have net seen this data: can yen please previde. Laura Elerrns em Lima T:r: Dave 13:: {lent-ire Mary Etc-ts. 03.25 PH Jtp?. Fla: Camel pesiive cure-ea ?LY-Hughes thate net seen this data: can pee please prewde. Laure Sterms U.F.. Regulateryrt?inieal Attairs tl?tlualitylI Assuraree Olympus Eerperatien at the Americas 350D Cerperate F?tarltwattr Center Valle}; PA ?lEElEd 1?Daee [8:15:16 PM-uh'layhe there is serne eent'esieh. I ltnew that we share the results et antr testing that we rile en euste were Da're Te: Lauri et- Bennie tusaawm ?atmates-gem. hit-rs am D1 $143331 ?1 {3:15 PM 1 Ha: Earn-El pea-little r? Maybe there is seine eentusien. I ltnew that we share the results at any testing that we de en eesteeter seepes with the eestpn'ter. What iwas referring te was sending Cert-tel a eepp er the genetie testing that Marti Ann had Mi?r??hen'l perterrn 1?2 ntenths age with GPA en purchased reference miereerganisrns. These are mt?tirdng resistant at the same type. but etwieesly net identical tethe Cernel eeleres. Itheught Cereelweuld penetrt trern seen; this data. Isest Regards, David David E. Eartew. Vice President Teehnelegy Assessment lElinieal Attais Medical Systems Gteup Olympus America the. 35GB Cerperate Pathway Center 1 ll'altett. PA date. barlew? l?Laura {12:54:55 Pitt-"Yes. it is per praetiee tand peliepi te share results with De my reply.r indies 1: eat Laura ?t Des-e tile-nee Ca: New F'l?ll'l [in-ta 112.5% PHI EliviT-t't Fl'a'. pal-i?! cuttde 't'es. it is eur practice {and pelieyjl te share results with eusterners. De yeu think my replyI indicated etherwise? I am eeptring (?Jennie as she is atse a eentaet tn the eustpmer and wenld predde any Nelsen test intern-rattan te Cernell Laura Sterms BLT-Hughes BEDS-193 UP, Regatateryrcinieal Attairs a Quality Assurance Ulyntees Serperatien at the Americas 350i} Careerate Center Valley PA 13034 [?Daye Etariewn-Dti'tatitittat ?2151:36 Phil-"I agree with year respectse. Etut I think that we netlrt send the Miereehent test res hits that we haye Dane I 3: Laura Many Finn Diesltech'HDihk-EIJSEI D2151 PM tasty-rt entities I agree with year reseense. Set i think that we eeutd send the Miereehent test reseits that we hate wih EPA as. drug-resistant E.eeli and I-ttehsiella te the austen-ier fer their edueatien. tthinti that it weuld derriensl rate in thernthat the HLD ehenieal {when used erepeily} is erehably net the erehlern. and they slieetd teens their search elsewhere. Best Regards, Etan Dayid E. Earlew. tries President - Teelinelegy Assessment ti: rSlinieal Affairs Medias! Systems Grade Arneriea Ine. 3545.343 Careerate Parkway Center Valley, PA days. earlewgtelyrrete .eern I?Latre Sterne-u-atrteizm A Plain-Hi Mary Ann - I agree with Bennie - any testing at Sides EPA as part at this eernpiairit iriyestigaiien 11 Laura. h'laty Init-tin hm it: {tennis- Date Data til-1 :1 SHIT-1 ?232 PM iatt He. Ger-Wei penalties cuilLIrds Hi Mary Ann - I agree with Bennie - any testing at Cider-r tit-PA as part at this earnelainrt inyestigatien sheutd he eerrermed by the ntanufaeturer. Hi Sam - sinee yeer eeritaet al Cernell est-ted yeu this guestien, I am preytdil'tg the reseense fer yeu te giye in year mutant. The ability at Sides GPA te Itill these miereerganisrns sheutd he reseended te ey ASP. Please tell yetrr eentaet that eur testing Laheratery. Nelsen Lae In Utah. ean preside ASP with euttures treat these patient it ASP is interested in pertetntirig this testing. ASP ean reaeh eul te Mary Ann staii already hate 3 relatienshie with Mary Ann] and she can direet htelsen te sent these patient euit tires in ASP fer testing. Fieg ards, {BLT-Hughes Laura Laura Etern'is Regulaterthinieal Attairs a Quality Assurar'ree Eerperatien et the Americas ssee Cerperate Parkway Center 1 trialley Fa. tsesat [?i'ylary Ann Dresneek-u?t?rlii??la Cit Marti} Pia?"Hi Laura and Daye, Cernell has asked it we wedld perierm testing with the erganisms that were isela 'r-I'n Mary?u'ln ?resnaeerClr?JedicaUDAI Laura ?mmsr'HarEerpr?aE?N. Dave Earleth-ICt-tthdicali?al?-DH tic- tannin Date til-1:14:th {it :46 Flat Earp-ct Earnetpestye cultures Hi Laura and Dave. Eernell has asked it we weuld perferm testirg with the erganisms that were isetated frern their endeseepes [Eeeli and tillebsiellat te see it theyI are resister te EPA. I'rn net sure ifthis is that we weuld server as part at eur eemplaint irwestigatien. I'm alse net sure that Nelsen weuld eyen be able te tie that. Thoughts?! I'iad pretrieusly asked Nelsen te held en te the cultures in ease we want te de any future testing with them. But. I hadn't pla tned en deing this as part eftheir pen-plaid. Thank yen, Mary Ann Dresrieek. MS. CIC, EFER. Manager. lnl'eetien Central Medical Systems Greer; Diympus America Inc. 35th} Eerperate Parkway Center 1 trialley. FA - Fair: {45:1} see-r15? This message. and any attached file5. is intended enly ter the sele use at the indiyidual or entity te which it is addressed. and may eentain infemtatien that is priyilegert eentiderlial and exempt trem diseiesure mder applicable law. it yeu are net the intended recipient, yeu are net autherbred Ie read. print. retain. eepy. distribute er disseminate this message er any part at it. It yeu haye repeiyed this message in errer. please natity the sender immediately by e-mait and delete all eeptes ei the message. Femsrded by Mary .Ig-in en 314.3314 Hall Freer '5:le Tub-Hamil Te Meryl-hat ate." tilt-31 Piu'l Re Fw: T311d1' Update ughes tdun?t knew either are we geing la de it. It eyer. this shcutd be taken by the manufacluer at the GPA. Haye ycu ashed Laura ahctl this? Cannie IS TLttEt'a Supery'iset'. Regulatory Affairs sedans; Affairs a ?eet Assurance Olympus America Inc. 24bit Ringweud nyenue San Jase. EA 95131 f-?T Fat-r: 935?5081 ednnietuberaely Winds-sent EDHFIDEHTIALITT This and any attachnents may centain pr'ebrietary and priwleged ter the use at the designated recipients named abeye. Any unauthorized reyiew. use. er d'elributicn is prchibited. It ycu are net the intended recipient. please cantact the sender reply email and all ecpies at the enginal message. i?lti'tary Ger-rite. Barnett is asking it we wauld dd testing with these ciganisnis tc see it they ate can Itth Ann Bresmcw'd?fhkditait?ht T: tannin TuanIJME-iu?dic?l?hla??d Deter til-1:14:20" HIDE Milt burn-st Fw: T3114: Update Hi Bennie. Carrie" is asking it we wculd dc testing with these crganisnts tc see it they are GPA resistant? I dcn't I-tncw haw we weuid dc this er it its even dur responsibility- What dc ycu thinI-t?? Thanh ydu. Mary Finn M5. BIG. Manager. Intestinn Central Medical Systems Erdup Diyrnpua America Inc. 35bit Carpdrate Parkway Center Valley. PA 15034 .- Fax: [454) This message. and any attached files is intended cnly fer the sale use at the iridhidual cr entity tc which it is addressed. and may centain infchiaticn that is privileged. confidential and exempt tram under applicable law. It ycu are net the intended recipient. ydu are net aulhcrised 1c read. print. retain. ccpy, distribute er disseminate this message at any part at it. It ydu haye rece'md this message in errcr. please nctify the sender itnrtediately by e?rnail and delete all eepies at the 11ng [113133496 message. Farirrarclecl be Ii'pry' Ann an El El'ls?J?i F'c- 11 Burn FUN h'hry?m Illa: Cesar Err: ?I'e mutEa st'lrlarl'e Date-2 {13233 PH He. Fw'TEI-lhl? Update _llMary Am, The Inlectien Central Manager at Carnell wanted in ltnew if we are able to determine if these prganisms are GPA. resistant- This email may centain key points asseciated wilh the reprecessing cit Equipment antller accesspries. Please nete that yau sheila always censul the curresper?ing instructien manual as the authoritative suurce et instructions ter reprecess'ng. 1 hanl: yeti, Barn Enauscepir Suppert Specialist Regienal Service and Repair - hladheast Ftegipn in? Regional Dt?ce 1.356.3??f?1 E- Natienal Service Hetline E-Mail: samesteuezt?elyimtscem Web: l?Mai'y Ann D3125115 Phil-"Hi Sam. are the results far the Cernell cultures- Ta Bent 13:; En: TaungrEasutl-Ieetum?lig??i Eesar [inta- 111? PM 1-: .rl: iect 73114: U?d?tl f-Ir?? Hi Sam, Elelew are the results fer the Camel sutures- Thanl: yeti, Mary Ann Dresneclt. ME. CIC, CFER1 Manager. Inteetiert Central Medical Systems Greup America Inc. ssee Carperate Parmay ?enter Valletl. FA 1511134 Faint: {454} mariramtlrusneckgalympiuscem SLY-Hughes ?it-03497 Tris message. anti any attached files. is intended enty ter the sale use at the indiddual er entity ta which it is addressed. and may eentain infanhatien that is pridieged. eentiderrtial and exempt trem diselesure under appiirsahie law. It yea are net the irterided reeiplent. 1ire-u are net autheriaed ta read. print. retain, easy, distribute er disseminate this message er any part at it. It yea have received this message in errer. please netifyr the sender immediater by e-mail and delete all eepies at the message. =c-rwartlad by h'tsnr #an L?rres neslu-H?luedeaii?m err {11:11-20? 13115 PH F'snt' Carina Weetiuft? sCWae-drufrgr-elsanlahssemh- Ta L's: Ehriathe Walton HCmIan?nets-anbbseamt- I'Jttle C5237 PM Sal: tact 1'31 I42 Upch'ba- Mary Ann- Iarn mntaetingvnu in regards tn the nrganism identifiratinn {Genetic} testing requested in regards tn Nelsen Number I31142. the preliminary results are as fellews: Elevater Wire lEltani'lel Essherr?shfa Cd'r' hirfWater Channel ?r Hiebsie?t: prteumartr'rse instrument it'J'ebsr?eHa pneumonia? it are-J have any questiens please let me knew ervau can eantact Christine Waltan at ?dr malten?tnelsaniahseem. Carina Wuadru? F'rajeet Eeardinatar. Laler atutias. Inu- netsentalss.eem ELY?Hughes 3493 Te: Ce: . I From: Sent: Tue 2:44:39 AM Impedance: Nermal Subject: Re: Cueterner Inquiries Regarding CDC Received: Tue WEEIEDH 2:44:39 AM Thanks Jeff. Then maybe we aheuid pull the deeument from being pasted en Endewiae. It is able in be viewed by eueryene at this paint an the new documents link. Thankyeu, Mary' Ann Dreeneek. MS, GIG, EFER, Manager of Infection Central NIaianndreaneek?elymguseem (in Jan EM. at 9:29 PM, "Jefferyr Daniela" sgeffew.Daniela??lymnuaeeme wrete: FYI. JD Jeffery E. Daniels Er. Preduet Eanager Olympus emeriea, Ine. 3506 Cerperate Parkway Center Valley, PA ieffere.danielseelemees.eem ww?.elemeusameriea.eem This message, and any attaehed files, is intended enly fer the sele use et the individual er entity te whieh it is addressed, and may eentain infermatien that is privileged, eenfidentia; and exempt frem diselesure under applieahle law. If yen are net the intended reeipient, yen are net autheriaed te read, print, retain, eepy, distribute, er disseminate this message er any ear: ef it. If ye; have :his message in errnr, please netily the sender immediately by e?mail and delete all eepies ef the message. Begin ferwarded message: Frem: "Susumn Nishina? Date: January 2014 at 8:15:24 PM EST Te: "Jeffery Daniels? {Jeffere.DanielsQOlemens.eeme "Jasen Hehraf? Eeshie? "Tsurne Eateri" Tashire? ?y ?Hireki Meriyama" Dkune" {s ekuneEet.elympus.ce.ip}, "Haaufumi Fukuda" Djiie" Subject: Re: Custemer Inquiries Regarding CDC Dear Jefferywsan, Thank yeu fer contacting me. DMSC will review yeur draft teday. But we can net cemmit te make de yeur time schedule since werk time gaye is a few days. I will inferm yeu teday's werk pregress. Regards, Susumu sax s_r_r_r_r_rgr_r_x Susumu Nishina Chief Manager Market Duality Administratien Regulatery affairs a Quality Assurance Department MEDICAL SYSTEMS CDRP. E-mail: This e-mail may centain eenfidential andfer privileged infermatien. If yeu are net the intended recipient (er have received this e?mail in errer] please netify the sender immediately and destrey this e?mail. Any unautherised cepying, disclosure er distrihutien ef the material in this e- mail is strictly ferbidden. Jeffery Nishina?san, Please allew me te intreduce myself. I am Jeff Daniels, the URI preduct manager Frem: Jeffery Te: Susumu NishinafjpfelympusEelympus Cc: Jasen Michifumi Tsurue HaterifjpfelympusEelympus, Yeshie TashirefjpfelympusEelympus Date: 2D14f?lf28 Suhject: Custemer Inquiries Regarding CDC Helle Nishina-san, Please allew me te intreduce myself. I am Jeff Danielsr the DAI preduct manager fer specialty scepes. Part ef my respensihility includes the duedenescepe preducts. We haye recently been infermed ef a news repert related te nesecemial a. infeetiens transmitted threugh duedeneseepes. This has generated a number ef guestiens frem eur field representatives and eustemers. Jasen Ashraf, eur CD5 preduet manager, teek the lead in drafting a letter te address this repert, and we are planning tn release it te eur representatives. We have passed the letter threugh review in ear, and it has been seen by safes, publie relatiens, infeetien eentrel, and marketing. We intend te release it by Wednesday. The letter is attaehed, and we wanted yeu te be aware ef eur plans te release it. {See attaehed file: Custemer Inguiries Regarding CDC Final.deesi Sheuld yeu have any eemments er guestiens, please feel free te respend te Jasen sshraf er me. Regards, Jeff Jeffery E. Daniels Sr. Preduet Manager Olympus Emeriea, lne. 3500 Cerperate Parkway Center valley, PA 18034 jeffery.daniels@elympus.eeg This message, and any attaehed files, is intended enly fer the sele use ef the individual er entity te whieh it is addressed, and may eentain infermatien that is privileged, eenfidential and ewempt frem diselesure under applieable law. If yeu are net the intended reeipient, yeu are net autherized te read, print, retain, eepy, distribute er disseminate this message er any part ef it. If yeu have this message in errer, please netify the sender immediately by e?mail and delete all eepies ef the message. {Custemer? Inquiries Regarding CDC: Finsl.deewe EXHIBIT -- - . I - will 'r'ukiu HahjnnaJ'HGl'H-l-dieaHD-ll Tu ?zm?zml? 11:42 pm cc Dal-re Dunn]; Laure SteIme?HDIBerp-r?ht??m. leery.r hm Dleenneh??lMIedml?U?-i??hl Subaru Re AEGE rem-eels help learn Glyn-apes 1e lest Dave; "fee. I will dd- Thank: you. Best regards. ?Ir'ull'hu Tulie Hal-1aij Dimeler, Heellhelre vaider?elatiuna Medical System: Greup Murine Ine. 35m Carp-Brit! Parkway Centaur Valley. PA. 15413-4 Fax: {memes-1'15? yukie W.uirmpusameriui-mm This me?ege. and any atleened ?les. is intended only l'er Ina sole use of Ihe individual er entity In which it IS addressedand may mnlein that is privileged, uen?denlial and exempl frdn'l disclosure under applicable law. If yen- :ra net the inland-d recipient, fl!? ere nel autherized ID read. print. retain. mpy. dmlribula Dr disseninale this message or any part ef 1?rm: have renewed thir- meenge In errer. please new the sender by e-rnenil and delete all cup-lee er the message. Dare Harlem-1H HlkulmI?-D?dediel??m??m Dem-qr Mary Ann Stemer?ICe Lie-1:: 513312014 12:52 AM AEGE requests 1mm 13? UHMEWWE ?rum - Eil?l?l Dr- Wang eenleered yen ininellr. I weuld lulu: yen le arrange a tele eenf between Dr Wang and Ellyn-Inns lieu. ml. Mary Annd la fellew up an his request. Thanks. Danny - I include yen in am email shiny. Please see the email mrrespundenee bubw- duet F'l'l- Beel?uuarde. deH ULT-Hughea 0002252 {'31 Elam-id E- Barlow. Vice President - Teal-Inning?! Assessment-E- Cbnicil Affile Madiral Syntarns Gmup ?l?ympus Write: Inc- 3511: Camumte F'mlmay Cant-Hr Valley- PA 1 I-d-l-l-I-l claw . ha acorn Fernanda-:1 bar ?aw: ml?l??r an. :19 5-6 PM "l [hm Barlam'I-I Dathbcal'CJ-M 71!: E?g?hi MFU ONE Hazul'ur'nl ?r'us hin- Hired-Ii Helium Hkhifum: Mary Ann Dmsnu?M?-?Hedi??er?-JIEDM. Lauri Philip Eat-m ?rum-n Euaumu Tsuru-u Hiddenst Takayasu Dr: 0525-5- PM :Egrqm' 3. Re. ELSEE I?!an Fram- Ell'y Imus In: last Dear Ukunn-san, Thanh yam furyuur email ?Ma mun-cams We will la?: la Dr 'u'l?ang and g-?t marl: regarding whal their plans are East Regards. David David E- Elam-w. Phi]- ch Pres-1mm - Techmingy Assesmn: E: Cinlcal A?alrs Medical Systems Gmup Olympus Arnenca Inc- 3513:: Corporal: Parkwiy Center Valley. PA 15ml: dawmmw?owmpus?am Far-.- Shigtkl ?ll-lunm'] p?a?'mpuw?r?L?fMPUE Dam: Hsmfumi hm- leulti HEIHI hi Within-mi TM Mir? Ann Laura: 5t: rrnaIH?-?Earpf??i??hl. P'h Juan ?shrafm?m?ltdlut?hh??hl. 5am?: DH. "'r'ukm H?njimm??-?HedmaL?-?nREED-ill- Nil-?n Tsurw Hair-Hahn Tahayaw 02:54 AM 11.. :1 Re; .ASGE requests. help I'm-m ?lympus Ir: Dear Dawn Harlan-t. I'm Shlgeh. Dim 2i QMSG Rr'llfl?. a-mm ya; tehalf of Mr Fuhuda Lacauaa ha is null :31 lhi? WHEEL dua in business irip W'e understand sh?ufd nal their Euggiaitmn haup 432ml reli'llunshq; wilh ?ll-em. 5-: Wli am madly la mum-rater Iheir Eugnus?un baa-tally m: cancern 1n gel 311133 I V, an: r9 calm pmmdure by the EFF approach ii we unly fund the RFP activity DI AEGE and can?t the pruincul supp-curl. 1hB That's why please sending men-I positive l'E'Ple" and mum 3min can?rm me- I'ullmuing twu ?LY?Hughcs 2253 1} Ginsberg tut-1 gnu that the ASGF sees a need far mere data. an this subject. but it tie-ES rttJI hat-tit the reseiirees ICI- pederrn snelese-epe testing itselt.? . I I I we understand why they want In canniuet item the sleeve eventually. they WDUI-EI [the tie glue the Facilities message te rental-re their eeneem. I Tin sierra-at mere data, we thir-iI-t the-rt: are same ether app-reaches inste act ef Fer manufecIUrers preside the dete er ASGE and manufacturer me tie a pretecel end test. Den'tthetr censider such seereech? Wha: is this current schedule and when AEGE decide whether that.I cenduet EFF estt'ii'iry? If the-1ir are dieing when still they start he )?Ettl knew. the trelidetien ta st tar tieeihla endaseae-e requires sent delicate handling. theretere it is impartant ta their plan hate-re we accept their sun he sheh i appreciate tenet eceperetien. Best regards. ShrgeI-tt Ell-suns STST [ti-15 CUR P. Atteirs is Quality- Assurance Department 2-551 Ishi'sawa?ehe, Hachict?-shi. Tel-ten Japan Fair: +ht?dz?E-tE?31 E-i'ra'l: F- its-ae- Eatlet'xtHEtiMedicaH-DAIQCIAI - l'tEa eututlti Fuhude 'jpfijijtt?tthua i'ti 't'ct'slhie Shige'ti Hirehi Heisutta Uj:ie "Nesta:- arpi'?hlt?'??l. hitc'l'iiturni UM. huff Leure F'halia Jase-rt Ealtuci machisem?rmedicattnhii??ht t?uti-e ditch-De?ant Susurnu Tsurtie Hate-trip'e't-rneusgetympus. Hidenehu I?m-r. ice}; er. ASE-E re quests help here tie testertislciscc-pes Hi Item. I em in threte this attending the Frentie rs ef Endesceptt meeting. Th eret?ere I had the chance te tell-i te Dr. Greg tpast president at ASGE and stitl an the his taE Beard]- end Dr. Steve Edmund-e wise whe has been a participant in this discussians with Dr. titular-i9 {the current ASGE President] site-cut this request. The ASEE is ca nee n-ied sheet the martyr nt reperts at pesitwe superhue cultures. crirrianlr with sndesceaes with elevate's. Dr Edmunde-nri'ca mertlened thelt?te persenalhr hnetss at reperts ham '5 dealers. The recently had a centerenee celt 1n'itJ'i CDC te discuss the CDC's incesegetten at the incident at Lutheran General. and ether reperts e! superhue intestines. Ednturideti-irie: participated in th at center-thee eeil. He sa 34s that at this paint there is ne stein-i that the current design at endescepcs is at feet! He is guessing that the emblem rnagir he errar he the 55mg tenhnirttan He sail:l that if alter a cine-latent is die: uttered. tl' sheet: Wit FIT lh? teennicien is data; yeu may find hat he is detng his jet-.ii currently, But that since net guarantee that the technician did the jet: eeneetlgii en the dag,r that the incident happened. Hewetter. he else believes that it is dif?cult te clean under I'ie etc-eater and that there is the at building up debris under the eteeater which wilt cause the Ht El chemical tci be. ineffective He said that it is his apinieri that. the {times hiush has a lane distal tip which mat-Les it dif?cult te get It sampleme under the eteuatnr The retare there is the chance that technicians. ans net dieing a gnad jeh at cleaning under the elevater F15 {reu knew. in the Lutheran Gene-rat case the CDC did net ?nd tault with the Pi: ntatt duedeneseape either in design er in maintenance. and did r'et ?nd any errersin the reprecessing process Heweuer, the haspitat decided in gas sterilise- their dun-cl seat-ampere which seemed ta cerrect the ASE-E asked the EDIE whether they sheuld receittntertd that duade ?escapes be gas sterilized The CDC. said that it is premature ta matte this general recernihendeti-en because the problem the}; in eestjgatad at Lutheran wasjusl cine acceiint. The rs is net stride-nee that at large number atlaceeulnis a re having this pre hlerri. and given the dised vantages at reutine gas sterit;eeliert_ the-ti are net it at this lime Cir. Erl murtcleiwisz is ear-ti machined aha til. the patent-tel [er this issue In east-aids. He is guessing that many haspilels will start tn culture their ends scepes at ta lest their secretes with Channel Sheets, and there will he mere reperts at sensitive results. asks-cl Dr. Edmunde'nrt'c: what. type system he uses at his heeleitel. His heseital switched in the and hes aide same time age, Hisi haspital has a liver transplant program and they perferrn eri many patents. He is itieretere very eeneeined aheul superheate? Up In this paint ?it r?r?ht?ti?l net had 3 prahtem- asaed him whether he has ever nurtured his shapes and he said yes ard that that.I were atl negative Haws war they de net currently rcutin etti cuttu re their endeseepe s. He said there is he standard eess tar reut'inely culturing headset enrleseepes and there ise shsnee te get {else eesilive results end then whales yeti de? The EEG. ABA. and AEGE {and maybe ethEr inleelien centrel urge niitetiers]l are geing 1e have a meeting el? experts ts the issue further. Ur. Edmundewiez mentiened Ie the greup er. the euhtemnee eetl that he think!- lh?y sheute' invite industry representatives he the meeting as welt. Er Ginsberg teie me that the ASEE sees a nee: fer mere data eh this subject. but it rises net have the res-nurses Ie es rte rm ende seeps testing itself. Thereiere. tte titini-ts the ASGE Will seeitzng funding trern industry se "that the ASGE can issue at EFF in study endeseepe repressesing issues with streerhegs Eesieel'ly ASGE weeld est: fer es pa ble centers le euerrit study preps-sets. and then the AEGE weuld select the best erepessl and praises the funding fer the studyEsil. Beth Dr. Ginsberg end Ur- believe that it 15 trees fer Olympus te suppert this went. The-y stress the need [er date In this ares end the need te itnd eul west exactly Is the reetssuse i'er these rt:er I here that '3de egress Be st Regards. David Deed E- Eeriew. 'Iul'iee President Teehrtelegy Ass-s Esme St Clinical alt-Hairs Hediesl Systems Greue Elly-mp us Amen?es lee. 35W Centers-ts Perl-twat: Center "nil'elleyr PF. ?1 E3934 eerlew?elympus.mm Fw-i Helufurr?? queues us Daw El-tl Teshie Tsshirerjp.?e ymeusgelympus- Beige ii.- Clitune.jprelyresusg eiympus. ledti Hunt-'3 Hit-tsetse Mil-"f Ann -aura eel. Fi-irlip DeyiefriEre-trdicrlt?eiig?el. Jassn AshreFiH?iitteeielli'?AIgj?Al. Seitue unchimrit??Me-dieelt?hlgDAL ?fut-tee Susui'ritr Himina'ge'elyrneus?elytmus. Tsurue Heteriip?eh'rripus?eh'rmus Hl?lnebu Hirnurilnp'e ympesige lyrripus- Talley:in hi 15' ?1i'1TrED1e Eli-14H Alt-i t-rrl Fte: ASGE requests help- trerrl Elly-metre testendescepss User Have There yeu fer eenteetihg UNIS: en this matter ewes yeu email irerri Hatch-sen. and reels wed It. Eric: the its net tinew what type or EJppurt ASE is asking Fer. eeuld yeti please ?nd eut frern ASHE es Fullness; t1} ef studies that AEGE is sensids ring. What support ASGE is 53" Glitter-tul- Ease-d en that iri?ee'ttstien. OMS-C: Ityi'l deliberate Glymeue user's ASHE er net Thanh yen for Best regarde. Hezu?Jmi Fuitude Eenier Market Quality Administratien. Hegtliatery A?eirs E- Aesthetics Dept City 'npus Medical Eysts'ns Gerri. 2951 lshil-tetye-meelti Heehiej-shi Tel-tyre Jepen - .I.- - - - - - Fart. +BT-[t2lt42-EitI-ta 31H its zufurni_tultuds ?e I. En Fenyertied F'e't'i Felwsidee [32-1 15-. EIZI titli'i'l? "4:14 eL tit?Hughes From Michifumr Tsuruo Hatoridpfolympus?otympua 13:: Miehituml Mary Ann Laura Philip DoyleIHQrMedicab'OAl@OAl Jason Sakuo Machidar'H Yuklo NakajrmaiHQrMe-dscalr'OAlQOAl. Hitoshi Watanabetjpfolympus@olympus. Dave Yoshio [Jett- 2014.'01116 05:2? mister 1; PW: ASGE requests help from Olympus to test endoscopes Thank you Dave. But you sentto Watanabe-san. So i forward it. And add Ta shiro-sa n. by lJichifumr Yoshic HOrMcd-catrOAl on 2014:01'5 15:1? F'o-n: Dave BarloerOr?McdiooIJO/Kl To: Hitoshi Cc: Miohifumi Yoshie/HQiMedical/OAI@OAI. Mary Ann DrosnockiHQ:MedioallOAl@OAl. Laura Philip Jason Sakuo MachidafH Yukio Naltajimar?HQfMedEcalr'OAlQOAl D: to: 201401315 12:25 Subject ASGE requests help from Olympus to test endoscopes Dear Hatori-san. Please see the attached email. it is from Dr Ken Wang who is the current president of the ASGE As you know. the recently reported incident with Pentax duodenoscopes at Lutheran Genera! Hospital made news in both the generai media and in endoscopy 8.. infection control related media A few days ago the ASGE and SGNAiointly sent out the following report to their members [atlachment response to reports of CRE infection transmission via ERCP pdf? deleted by Dave Since this problem at Lutheran General Hospital was reported by the CDC. OAI has been many inquiries from our customers regarding Olympus' response to this incident. They want to know if the so me problem can happen with Olympus endoscopes and Otympus AERs. We are now working with Marketing to draft a response which we witl also send to OMSC for your review. However. we are assuming that many also contacted ASGEISGNA with questions about whetherthey should be concerned about similar events happening in their hospital. and whether they should change their reprocessing technique based on the new threat of 'supe rbugs"- We assume this is why the ASGEISGNA sent out the message above- However. we also assume that ASGE now realizes that there is not much data available regarding the impact of these so- called "superbugs' on endoscope reprocessing. As you know. there have been other reports from the US and France on multi-drug resistant organisms being cultured from endoscopes. most often duodenoscopes. and the number ofthese reports is Increa sing. As a follow up to our intemal investigation of "superbug" problems at UPMC. 0A1 decided to perform some basic to on the abil ly of Acecide and Aldehol [our products] and GPA (which was used at UPMC and is a common HLD an our market) against a variety of multi-drug resistant organisms. The ?rst study showed that these HLDs quickty Kill these microorganisms when they are in suspension The second study showed that these same HLDs kill these same organisms when they have been inocutated and dried onto Sections ofduodenoscope biopsy channei material We had discussed internally in ON whether we should now inoculate intact duodenoscopes. disinfect and cutture them. to show that our processes are effective against these microorganisms However we are holding off doing this study since it appears that based on the tests that we did perform these superbugs are not ove rty resistant to disinfectants. just antibiotics Therefore our reprocessing process is effective against lhese superbugs. In other words. a standard challenge of 10l096 of mycobactena is a much tougher challenge than these organisms and our process does not require revalidation Here are copies of the tests that we did perform We intend to make these tests available to our customers who are asking for data/information about these so called Superbuge [attachment 'Microchem lab test Acecide vs Aidahold vs Cidex OP against drug-resistant organisms in suspensionpdt" deleted by Dave Barlowll-lOiMedicallOAl] [attachment "Microchem lab lest - Acecide vs Aidahol vs Cidex OPA against drug resistant deleted by Dave BartowaQr?MedicaltOJ-?ill OLY-Hughes 00022 56 Hate-raver. tram the cmlil bcidw- II appears ihal AEGE is E?l?tdalin? inddutaling mm! and lasting that! can achiaw high disinfech With u-Lm particufar rn-i'crudrginisms. They are limiting far :upp-crt from fur than: At paint we [in nut I-cnaw what :ypa cf supp-art AEGE IE Elsi-ting hr- it ?uid but It'll- lid-an It muid funding. llcduid tun Sincl- teal is 1155:: mutuallyI 1 trairatitlntidn cf the In dam:de mamtadturar': tEpi?DEl?-Sing mitimd. WE bailim it is dqciaitin Diympm shunt-d wart with AEGE UT nut- GM wuuld il-tu tn ASE-1E. and will watt; with HEGE- but ma need It pun am nut the ccrract perscn ti: this fin-mam it It} ?Ht-El carract paw-tin. 1N5 wuuld appreciate a quick reap-un?t that we can rcpt]; to ASHE in a Emily fashian. Thank ydu. Best Regards. David David E. Baddw. "ul'ic: Presidun?t Tuchriuicmr Amamnt I. Clinical Medical Systems Group Arm-rid: Inc. 35th: carpi:th Parkway Canter Valley PA 150-34 I-I I-I Fawn Than. Henri-2h MD {wing Henmihgnuyd ddu: 'Tuklc cdrn' Nil: cit-m:- U1 a??l?ld 131115 PH 55:. Inteclidn ml reprocessing I'll! 'rt-iz-u '31: :4 E. Hlf'FIu 11-. Mani amt-m u. li-r 4151a!" 1: 2. iL .r-tr cm: dc. Elm: [2:5 'L'Elhl'? -I law-13 I -l .1: f" - II-nll- sdff'll'ttl by: I :in - i'l {SILT-Hughes Tc: piraiHQiEerpr'DAI Etta D?ll?cn ny_S Ncemi_5c hambachiH?tiEe rprc-ans i_Sc hamhachiH?tC crpiDAl?t?tDAl] Cc: I. {All Eli i'v'l edicalr' [Eta vid_Leihyt Di llr'iedicalrr DNan Frcm: Sent: Men 4:1l]:43 Pl'vi EXHIBIT r? us Narmal Subject: LINE call at 3:33 EST teday Received: Men wwde 4:113:43 PM Hi all, Dr. Rdtala is a call afternadn at 3:33l EST te discuss an an-site visit and ether details ethis inyestigaticn- is anycne able tc jdin the call with me? Thank ycu, Mary Ann Drasnach, M5, CIC, EFEP, Manager. lnfectian Central Medical Systems Grade Cilymcus America Inc- 35IDD Parkway Center Valley. PA 1303-1 Far-r: {434} maryann .drc ancck@ cly n?ip us cam pus america .cem This message. and any attached files, is intended enly sale use at the individual er entity tc which it is addressed, and may cantain infermatian that is privileged. cen?dential and exempt tram disclesdre under applicable law- It ycu are net the intended recipient. yeu are net autherised te read, print. retain, ccpy. distribute er disseminate this message cr any part at it. If yau have received this message in errar, please nctify the sender immediately by e?mail and delete all ccpies cf the message- Heisuke Ujiie-u?iti?iliz?m 1211:4323? PM--?Dear all, I shared this camplaint with DMSC. The fcliawing are advice tram them ta investigate at th HeisLhe Tc: Laura .35 Mary Ann ?mganH?jME?i-Ealf??h?l??llI Danny shapIrgrl-lrgr?nmmaug?al Bennie Tubera?westr'MedicaIIDAItQDAI. Dave EtarlawthJiMedicali?al@DAL Jascn AshrafiH?rlvledicalr'DAl?rGAI. Russel Haemi David Richard Camplaintsti??l, Susarnu Hishrnar?jptelympusn?elympus, Hunimcri Hail-?Um l'ulichifumi Date: Mt?d??le [11:43 PM Subject: Fte: URGENT GDNFIDENTIAL - UHC cvlturesfrem Dear all. I shared this cemplaint with DMSC. The fellcwing are advice tram them ta investigate at the facility. Please investigate the raprccessing princess ta the attached EDS checklist. We have tc get the intarmatien en net anty raprccessing steps but alse detergent. thshes, and disinfectant that LINE: used- The hlaclr highlighted investigaticn items en the check list are HGT indispensable. [attachment checkiist?reyisianff'l .dbc? deleted by Mary Ann Additicnally, DMSC expects the inyestigaticn items will be ayaiiable. What are the cf 3i] sccpes and 13 pbsitiye scapes {Mcdel# and UMSC believes that the has cf culture tests. I I Were there any changes after the ?rst week? The percentage of pnsitiye scapes in the ?rst week ts higher than in the last weeks. e.g. Filters. Disinfectant sclutian-.. It What cleaning brushesiMbdelffj: were used up brush the sucticn channel cf the What were the canditicn cf E-rush heads if the custerner used reusable brushes?? What is the rnethbd cf culture tests? Uses the methcd haye any that influence the result cf test? When did the custcn?ier start using Was asset cf What disinfectant saluticn did the custemer use? Acecede-E er Wl?tat is enteric micrcbe?? If ycu have any guestibns. please ccntect me. Best regards- Heisui-te Lijiie Engineer. Regulatbry Affairs and lDuality Assurance Liaiscn Medical Systems Grcup Garpbratibn cf the Americas Edtilt} Avenue San Jase. CA 95131 1 I I - I 1' E-mail URL ?ame Starrns--?2Ci?i4t04ffi? Mary Ann thanits far the update- Denny please reach cut tb an this campiaint and see if Laura H?f Ed rp.r 3A1 T-a. Mary Ann Drasnach'H?fMedicalfDAltEDAL Denr'y ShapircfH?l?erprAJ?DAl I I I Gs: Cannie TcberaA?JastrMedicaerAlrg?Al, Days Earlpwa?fMedicalf?Al@UA1, Jasbn AshrafrH?rMedtcaerAli?DAl, Russe Halsulte Naemi Dayid Leibwucruadinalrcsugcst, Richard usmiEssuMeuicsircsug-cst Date: 2D14f?4t?3 cats? Subject: Fte: URGENT: EGNFIDEHTIAL - cultures - -- - '5 Dear Mary Ann - thanks farthe update. Danny please reach but tc- DMEE an this complaint and see if they wish us is bbtain any specific this site visit. Thanks Laura UR. Affairs A Ctuality Assurance cf the Americas 353d Parkway Center UalleI FA EMEW Ann tidz?iiz?? Flirt?Hi all. Dr. Rutala called me this unanncunced a?erl had tried tc set up meetings with Frcm: Mary Finn Tu Denny Lama Bennie Dave Jascn Russel Heisul-te Mcerni David LeibyrHEti'fit edicalr?alrgiijm. Richard Cc: Date D4i?2f2? H- PM Subject: Fte: URGENT: EDMFI DEMTIAL - LINE: cuitmes Hi Eill. Dr. F-iutala called me this afterncicn unanncunced after I had tried tc setup meetings with him at a speci?c time sc that Fi?. cculd be an the call. Dverall. he reiterated the message that was sent in his criginal email. Dr. Rutata feels that they have eliminated all envircnmental that they cculd think cf such as water. air. different technicians. different disinfectants simethiccne usage. They have had several pecple in tc evaluate their prccedure in the past including cur ESE with nc signi?cant ?ndings. Dr. Rutala feels that these are enteric crganisms representing previcus patient GI flcra that are present upcn culturing abcut east at the time. The sucticn channel has shown the highest ccntaminaticn rate. Based upcn the diversity cf crganisms being reccvered. he dces feel that it is an envircnmental scurce cf ccntaminaticn. Dr- Rutata alsc suggested thatl visit the facility {lilter next week} and evaluate the piccess again tc see ifthey are missing anything in their prccedure- He shared that tvtedivatcrs is planning an dcing the same. He will cc-ntact me with dates far a visit be and will be back in the US en Mcnday at which time we can ccntact him if we need mcre Thanh ycu. Mary Ann ME. BIC. EFEH. Manager. Infecticn Medical Systems Grcup Olympus America Inc- 350D F'arlcivsy lilenter 'v'alley. FA 131334 Fax: {434) 5T cltt?elympusccm .ccm This message. and any attached ?les. is intended cnly fer the sale use cf the individual cr entity tc which it is addressed. and may ccntain that is privileged. ccn?dential and exempt under applicable law- If ycu are net the intended recipient. ycu are net authcrized tc read. print. retain. ccpy. distribute cr disseminate this message cr any part at it. If ycu have received this message in errcr. please nctify the sender immediately by e-mail and delete all ccpies cf the message. E?ichard 11:ti9:1b?u refill-?Fire there any cther envircnmental issues that might be affecting these tests? Dave Lelby effered up Frcm: Richard Tc: Denny ltic: Mary Ann Laura Bennie Dave Barlcer?ftits-dicalf??tlt?t?m. Jascn AshrafiH?flvledicali?-?ili??m. Russet HigginsiH?iMedic-sli?mgr?al. Heisuite Ujiiei?i?rasu?crpr?elt??m. Hcemi SchambachiH?iEcrprAI@DAI. David LeibyiHDiMedrcaLiDAl?CiAl Date C'Iif?EiE'??ld 1 LDEI AM Subject. Re: URGENT: GDMFIDEH TliftL - Lihtt: cultures Are there any ether envirenmental issues that might be affecting these tests? Dave Leiby effered up a geed theery abeut using air te blew cut the scepes_ Pessible that the air is centaminating the instruments? Dther envirenmental facters? Richard Metre Directer ef Hegienal Service Regienat Service 3.: Repair? Seutheast Regien Medical Systems Greup America Inc- 135i] Herthmeadew Parkway Suite 12D Reswell, GA EDWE Regienal Dttice: Hatienal Service Hetline: Laud?3439134 Mail: richard.metre@elympus.cern Web: NDTIDE: This message. and any attached ?les. Is intended enty fer the sele use ef the individual er entity te which it is addressed. and may centain inferrnatien that is privileged. cen?dential and disclesure under applicable law. It yeu are net the Intended recipient. yeu are net autherised te read. print. retain, cepy. distribute er disseminate this message er any part ef it. it yeu have received this message in error. please netify the sender immediately by e-mail and delete all cepies efthe message. EDenny 1135131 The tact that pesitive cultures are seen with bath DER and Medivaters suggests that reprece l'rem: Denny SiapireiHDJCerpiD-?-l Te: I'v'ary?nn I Cc Laura Cennie Tuberamlesv'MedicaliDAltEDAI. Dave Jase't Aehrati'H?iMedIcali??lg??l. ?atsulite UJiie?Mesti'Cerpi'DAlLEDAI, Mecmi ScharnbechiHDihrpiDM-??Al, David Richard WetreiEastil-il Date. 11:05 AM Edbject: He: URGENT. DDHFIEEHTIAL - LINE culturee frern Thanks. The fact that pesitive cultures are seen with beth DER and Medivaters suggests that reprecessing steps are net being fellewed Denny Shapire Directer. Hit-18.0.5. Derperatien cf the Americas Medical Systems l'3reup 24m} Ringweed Ave- San Jese. ca 95131 Emery Finn [3115344 Attila?Hi Dennyr Yes. an ESS was sent euteriginetly when Dr. Hutala neti?ed us et initial results. He rent: Mary Ann Te: Denny ShapireiHQiCerpiDAl?D?l I Cc: Laura Etermei'H?i'CerpiDAIIEDAl, Bennie Dave BarlewfliDiMe-d calfDAl?DPil. Jasen Ashratirl?iMedIcaIIDAItEJDAI. Russel Heisulie Ujiiefh'vesti?erpiDAIiQDAI. Heenii EchambachiHDiCerpr?-J?DAI, David Ric-tare Metrei'EasttM edicaliDali?DI-?ul Date. mess Alt-1 simmer- Ha uet?sEivT: - cultures frern Hi Dennyr ?i?es. an E33 was sent eut eriginally when Dr. Rulala netitied us ef initial results- He was net using the at the time. but instead a Mediyeters unit- We can send the E58 eut again te matte an additienal assessmentas part et this new cernplaint. Dave Leiby - Can yeu please arrange fer this? Thank yeu. Mary Ann Dresneclr. M5. CHE. EFER. Manager. lnfectien Central Medical Systems Greup America Inc. 35Gb Cerperate Parkway Center Valley. PA 18D34 0-44 Far-r: {434] maryann.dresneck@elympus.eem .cem This message. and any attached tiles. is intended enly ferthe sele use ef the individual er entity in which it is addressed. and may centain infermatien that is priyileged. centidential and exempt frern diselesure under applicable law- If yeu are net the intended recipient. yeu are net autheriaed te read. print. retain. cepy. distribute er disseminate this message er any part ef it. If yeu have received this message in errer. please netity the sender immediately by email and delete all cepies ef the message- HDenny Shapire-u?ei?EIED?M we sent E33 te perterm en site assessments? I weuld recemmend this te be dene en Frem. Den ny hapirei?l l?f?erpr?r?il Te. Laura Etc. Mary Ann DresnecHHCirMadica MAME-DAL IBennie [Jaye Jasen Russel Heisulre Heen?ii Date: MIEIZJEHH AM Siject Fte: CONFIDENTIAL - LIME cultures ire-m Have we sent E55 te perferm en site assessments?? weuid recem mend this te be dene en different days in an etiert te encempass all persennel per'ferming Denny Shapire Directer. Cerperatien ef the Americas Medical Systems Greup 24bit] Ringweed Ave. San Jese. EA 95131 - ELaura Alvin-Dear Maryann - thanks fer advising. Ely easy at this e-mail. I am submitling this sempleint ts dur Frem Laura Slerm sJ'H?r?Eerpr'DAI Te: Mary Ann Ce: lBennie Dave Jasen Russel Heisu-te Neemr Denny Date: [Hill] EFEU 14 0423-5 AM Subject: Re URGENT: CONFIDENTIAL - UNI: cultures from Dear Maryann thanks fer advising. Ely may at this e-mail. I am submitting this eemplaint ts eur sampleint greup as per pelisy. Please make arrangement te have a member at the sempiaint en the phene fer yeur diseussian with Dr. Ftutale; I am sure thatEennie will sentast yeu. Cannie - please have Kei invelved in this investigatien frem the start as we may need DMSC assistants. Th an ks Laura Sterms RegulateerIinisal affairs at Quality Assurance Olympus Cerperetien at the Amerieas 350D Cerpdrate Parkway Center valley PA 1812134 Iaurastermst?elympuseem Elwiary Ann Dresneekn??-rll??lfa??lil $133119 Alvis?*Frdm: Mary Ann Dresneeka?iMedisallDAI Te: TuberaMesthedisaliDAhEeai. Dave Laura Fren'.? Mary Ann Te' Eennie Dave Laura Es: Ftussel Higg Jasen Date deletladtd mes AM Subjem URGENT: CONFIDENTIAL - UHC cultures from Geed merning all. Please see the email below frem Eir Rutala at UNC. He is reperting pesitive cultures from his see-hes after in the Nets that his email was sent he hath myself AND my eentast at Medivaters stating that he's seeing the same euteemes frem beth units. This is the ?rst report that I've heard frem Dr Rutala and he wants ta have a discussien with me temerrew as I?m at HORN and traveling teday. I will set up a sail with him temerrdw. Please let me knew ifanyene has any theughts er infe that they would like me te share with him an that call. Eb Thank yau, Mary Ann Dresnecic, M31 GIG, CFER, Manager, lnfectien Centrel Olympus America. Inc. Begin forwarded message: Frem: "Rutala. Bill [EpidemiclegyT' Date: March 31, 2014 at PM CDT Te: '"Eiremiley, Nick'" sMaryAnn.Dresneckr?elympuscema IEtc: "Sickbert-Bennett, Emily" sEmil .Vayalle unchealth.unc.edu} Subject: CONFIDENTIAL Nick and Mary Ann?Yeu knew that we have been inyestigating pesitiye scepe cultures fer the pest seyeral menths. Eelew are test results ef sampling 3t] scepes ever the past three weeks. es yeu see. there was he difference in the centaminatien rate between Mediyater and Olympus AERs. What is net apparent frem the data belew is that EH13 pesitiye endescepes er 69% efthe pesitiyes were feund in the first week and enly 4f13 endescepes in the last twe weeks. As yeu knew, the natienalfinternatienal standards are that endescepes be cempletely deyeid ef micrebial centaminatien befere patient use. We are ?nding ef tested scepes centaminated with enteric micrebes pesitiye frem suctien channel). The eyaluatien has been dene te determine whether eur practicesfreprecessing actiyities are deficient and need cerrectien er the natienaltintematienal standards are incerrect and the natienalr?internatienal cemmunity ef endescepe clinicians need te appreciate that with current reprecessing technicianitechnelegy 40% cf the time pctentiai GI pathegens may be passed frem cne patient te anether patient. I am beginning te believe the latter is true. This is a critical issue fer US hespitals te reselyefunderstand te ensure patient safety and I need yeur input. As yeu are well aware despite substantial time and effert we haye been unable te disceyer the exact cause ef these pesitiye cultures and implement a strategy te preyent centaminatien. If pessible, I weuld Iii-(e te talk te yeu temerrew er Wednesday as I am Ieaying fer Brazil en Wednesday night. Thank yeu. Eiill William A. Rutala, M.P.H. Directer. Hespital Epidemielegy, Dccupatienal Health and Safety Pregram UNC Health Care Prefesser ef Medicine LING Scheel ef Medicine Directer, Statewide F'regram fer lnfectien lSentrel and Epidemielegy LING Scheel ef Medicine Chapel Hill, NC ETE14 FAX: 91 9936?1451 Email: brutala@unch.unc.edu Endoscope Sampling, March 2014 30 endoscopes samples-17 in lVledivator, 13 Olympus 13/120 samples (4 channels per scope sampled) positive-10.8% 10/13 positives were suction channel 7/17 positive scopes were from Medivator-41% 6/13 positive scopes were from Olympus-46% Confidentiality Notice The information contained in (or attached to) this electronic message may be legally privileged and/or confidential information. If you have received this communication in error, please notify the sender immediately and delete the message. EXHIBIT -1 a 1?1 I From: i i To: Sent: M21 l2?14 11 3:13:45 AM Subject: Re: Question on endoscopes from Dr- Hotels at UN: Su'e Laura not a problem I will work on this today Thanks. lConnie t3 Ttloera Superyisor. Regulatory Affairs Rituals-Reg Affairs 3 Dual Assurance America Inc. 24W Ringwood Avenue San Jose. CA 95131 nL-l-I. Fat-r: id??i 93 5?5t?l??l connietuheratmolympuscom EGHFIDEMTIALIW NOTICE- This email communication and any attachments may contain proprietary and priyileged intormation tor the use ot the designated recipients named aooye. Any unauthorized restety. use. disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply entail and destroy all copies of the original message. I Laura It e?z?Tfld Alvin-Dear lConnie - lit tip at of all the questions from l'tei and Esau. taint: the llilomptaints department nee tn Laura I Connie Tuber: t_.r star-e I'll-r E-cvc tit-Jails; l'runny Fill Ipiltl-If?lch L?trt'rl'un'i ?r'otd: Ems-Iran [-r-te 112411: osor sill Sutject Re; Question on endoscopes trom Dr Rdala at UHC Dear Connie In light of all the questions from itel and Haau. I thll'il-t the Complaints department needs to bring together the key parties inyestigating this complaint so that we can have some order and assignments. Clearly Mary Ann can proyide assistance trom a microbiological perspective. but it is not her responsibility to pull together all this other information- can you please make assist in this regards. Thanks Laura Storms wit. Regulatoryl?linioal Atlairs d- ?uality Assurance Olympus Corporation of the Americas 350i} Corporate Parkway V?ll?l PH 13054 Plain-Dear Mary Ann. I understand he has requested the suerface area of the channel- GILT-Hughes 1:59 Fae-11 T: mff?m t2- Berni-.- Dave Elia U'Cl?'lrl' ?in?ame Um?m- Laura Et?'m? H3 Mel-irate Tau-m: Hataridpeempue {ate -.rrn:ir.us. Eusumu Hmimen July ?d??ii?id EE- PM Sewer: Re: Questlen en end-esceper. 1"er'n Dr. ?lial: at Dear Mary Ann. I understand he has requested the euert?ace area cf the channel- De tree knew what Inedel name he Ie Interested In? I Addilienalty, did he tell yeu whet heweul? litre te de train; the euertaee area? lweulel aeaurne he tries te calculate aernething. Regards, Haaufemi Fukuda Senler Superviser Market Duality Adn?rinietratien. Regulated.r Attaire ?uel?y Aaeuranee Dept. Medical Syeterne Cere. 2951 lel?ril-tawa-machi, Hachieji-ehi, Tel-tyre Japan Fae: .ee .jt} I?Mary Ann Dreerreclt-nEDHJCIIi-?H Dzzl?z??-uDear Head- twill were an gathering inte'matienter yen and cementing it inte erre entail. Pleaee 3! ln I'Ii?nljl Fun Bree nezhHG?hhthall?-MIQUN Ta. Hazufumi I Cent-lie Dave D?l?ln'f eel: Lite Ujre?r?r'e: Laura. Hermit-IE} Empi?mg MEI- E?m?hl, Tani-Li: Eeemmr Hiring-jaw? Hmimeri Dill? 5 Fm; en ertdeeccpee Ire-w Dr Flute'e 31 Li?: Dear H3511, 1 will werlr en gathering irrtermalien fer tree and cernhining it inte ene email. Please alee nele that Dr. Relate has requested 1e knelt".r the surface area ef a celeneecepe inetrurr:entr'euctien channel. Tlten'rl: firedn Mary Ann Dreeneck. M3. CIC, CFER. Ma eager, Infectien Centrel Medical Syeterne Green Glyn-lees America lnc. Cereerale Penney tenter ValleyFee: {-434} marvenneresneeh@elymeue.cern wwelympueer?nericacem 0L Y?I?lugltee (1121351?!) This message. and any attached tiles. is Intended enty far the sale use at the entity ta which it is addressed. and may cantain inlannatian that is privileged. canlidential and exempt tram disclasure mder applicable law- It yau are net the intended recipient, yau are net authdrisecl tci read. print. retain. capy. distribute disseminate this message any part at it. It yau have received this message in errar. please natiry the sender immediater by email and delete all capies at the message. l?Hazufuni Fultletl-?-D4f13i2?14 a4:as;1s Alvin-Dear Mary Ftl'll?l. Thantr yau tar interming us at Dr. Hutala's questlans. cm. Hunter-til Mitrme 12L (immis- Tuherai'tl'u'esh'hl'redica Dave Danny tic-1's Lite liutal. hl'l-ehiruhi Ts true Evsumu Herinaypfalympusgahtnpuc. Its-timed "r?ar'rtegueli?ip Dz're M'ta'EDt-? Hi? tightest: Re: lEtues'llan err erudescnpes Ire-m Dr Hutsla at UM: Dear Mary Ann. Tha ynu fc-r infmming us at Dr. Huala's questions. 1 held a meeting with the experts In DMSD. will prepalr answers ta his guestlans by April 30th. Tu get a better understardirg. cauld yau please give us additianal infarmatlun an the tallawtng taur paints: - Haw will he utilize answers tram in the panel discussian at the EDNA conference? Far example. will he present the answers as atlicial statement tram Olympus at the EDNA centerence? 1thrill he use the answers withaut mertisning eampany name?? etc. - Dist published the Buick reterenee guide and the custamer letter regarding the test results at Acecide-C and Atdahcit ta evaluate the ef?cacy against several drugvresis1arlt arganisms. wander Dr. Ftutala received them. Did he pruvide yuu any camn'ients an them? Additianally. DMEC was intermed that his haspitat's scopes have been tested pasithe tar micraarganisms. Dist had a meeting with him. and is wanting with him In try ta identity the satires. I Cauld yau please briefly explain current status at the culture test results issue? was seated an same ernaiis. hut wauld lite ta grasp hig pieture.} Dr} yau think he wauld litre ta present the answers as rnanutacture*s this issue- Thanlr yciu fur cantinued suppart. I am lent-ting terward ta hearing tren?t yau. Hazulun'li Fuhuda Sealer Supervisar hilarlret Duaity Administratian. Ftegalatary arlairs Duatily Assurance Dept. Medical Systems Carp. 2951 Isl?iltawa?machi. Haehiuji?shi. Tattyu 192-35131 Japan - - - 1 - Fas: +s1-rutte-ets-st T-rt I?lti'iary Ann all. I need yaur help in getting answers ta Dr. Ftritata's questions helm-r. This intermatian is GILT-Hughes Fre-n lr'hry .ltnn Ts Iteistdre Ute-mast ?I'd-s h?efHD-?hhdcalt??lg??. Tsurue Mtrihlte Halt?'fuml Eelyn-pus C: Date: laura Sterms-th-Eii?erp??t??m Denny ShapdrefH?fEerplG-A??F-l. CeHnie Dal-1" Will? Sunset ?ue-sitar: en endeseepes I'rem Elr. at Llfli: Dear all. i need yeur help in getting answers te Dr. Rutela's questiens betew. This infermsiien is geing id be presided te SGhta. as part ef a panel discussien at the EGHA centerence. I can enty assume that is currentiy tallt-ng abeut the need fer sterile endescepes. especiain duedenescepes. and ether current issues. but I den't Itnew that fer sure. The guestiens are iighlighted in blue beiew. Please heh me in answering these guestiens ter Dr. Ftulala. As we are net the Mamrfacturtrg BC. I de net knew that prdper answers tethese questiens. Please lteep in mind that ear has repeatedly stressed the need fer GI endescepes that can be either steam sterilized er made materially cempetibte with hydregen Fl'Etl'DiltltIIB. We understand that cerrentiy there is he hydregen perende technelegy that is FDA cleared fer GI scenes. but I weuid bags that this is sernething that tit-MEG is weriting en threugh a partnership with anether cempany er an ear ewn. The marliet is calling fer this new and beginning te demand it. As yeu are aware. ED is net a cerrmen eptien in the us as west facilities have getten rid elr this technelegy. tde net ltnew with in DMSC will be respehsible fer answer'ng these guestiens. but we require them by Apnl sern. Dr. Ftutata has the SIGMA panel discussien at the annual meeting en fiilay am and we will need time te accemmedate his and my travel schedtle up te and prier te the SGhti-t centerence. Thanlt yeu fer yeur assistance. Mary Ann Dresneclt. MS. Elli, CFER, Manager, Infectien Central Medical systems Greta IL'lempius America Inc. 35th] ?erperale Parkway Center FA 1303!! Fax: [434} asset 5T marya NOTICE: This message. and any attached ?les. is intended enty fer the sale use at the indieidual er entity in which it is addressed. and may eentain infemtatien that is privileged. ceniidential and exempt frem disclesure under applicable law. It yeu are net the interded recipient, yeu are net autherized in read. print. retain. cepy, distribute er disseminate this message er any part et it- If yeu have recelyed this message In errer. please entity the sender imnediately by e?mall and delete all ceptes ei the message. FDrwatdc-d by marry his en [idilTa??lI-i 10:53 Mull run 'Huteln. Etil [Epidemlehm?? Llein?meheaithmne red-u:- T11: 'rnnr'y'enn smaryann drdeneclametympue came. 'Etremllay. Hieli.? inbremileygmez?yatdrseema Date 15:15 Net Jt?t?t Nick and Mary Ann-I are participating en a panel at sees and there are a ceuple guestiens that I weuld til-.e yeur cpinien. Thank UL T-Hughes ??35 172 you. Bill How far are we away from sterilization oi endoscopes? Where are we at this point? Is there something in the works? What are manufacturers doing to provide scopes that prevent lower infection risk and investigate how the scope design may have contributed to the recently reported CRE outbreak? um Hm (armrr?imf in (or tiffh'?'ht?d (or (hit trunit- mummy may or h'grri'rji' ,rJr'r'i'ir'rguc'st'and or (ori?u?wirm! Hr?u?rmm'rm. Jim?s this tm"nurture-arm? in error. picuw nuriifi .w/rth'r mmit-dmrr'Iy and tit-fert- rht- OLY-Hughes 0035173 Tc; - Ha: ufumi_Fu Cc: Frcm: Bent: Men 5t12i'2l2lte 1119:33 PM Impedance; Narmal Subject: Fte: Fw: reg uest letter DAICDRH regarding Medal and related duedenesccpes Received: Men 5l12l2l314 PM Hi Hazu - DEA is en the answers tc ?le an D10 and we will add these tc the draft letter. and preside DMSC with cur draft. ThanI-r. trcu Laura Laura 3: Quality Assurance rDrirgcraticin cf the Americas 35GB Parlerirag.r Center 1lilalleii? PA 13034 EHazutumi 01:42:35 Laurar DMSC had a meeting an this request the FDA. Frem. Kazufurn' Fulrudai'jplc ympustEDL?fll?PUS Tc: Laura Cc. Hunir'te'i Susurnu Denny Date. [31:42 AM Subject: Re: Fw. lnferrnetien request letter I'rcrn regarding Mcdel and related Hellc Laura. DMEC had a meeting an this request frem the FDA- Ceuld San Jese preside me with a descripticn cfthe precess San Jcse uses tc handle related tc- cleaning.dislnfec1ing and reprocessing? Based cn input San Jase, I will draft an answer la the questicn #9 in the FDA letter- lEluesticn e- A descripticn cfthe precess ycu use tc handle ccn'lplalnts related tc cleaning, disinfecting and reprecessing- Thank ycu fer ycur assistance. Best regards, Hazufumi Fultuda Senicr Superviscr Market Duality Administraticn, Regulatcry Affairs at Dualityr Assurance Elect. Medical Systems Earp. 2951 lshilrawavrnachi. Hachicji-shi, Japan Fat-t: Td ELaura URGENT Dear Shiga?san. Tabe-san. Mcriyama?san and Murals?san Frcr'n: Laura Te: ?rcichi Hll?Dkl Hisac Alrira Shigaijplalympus@elympus Cc' . l'u'llchifumi Heisulte UjiieMesuCcrpIDAli?iDAl Date Subject: Fw: request letter tram regarding Medel and related ducdenasccupes URGENT Dear Shiga-san. ?fabe?san, Mariyama-san and Murata-san The FDA has sent the fcllawing request he me tcday. The respanse is due ta FDA cn June El. lam reset -- - i. In Cassi h' I . - ft- DMSD needstcimmediatelydeyelapa warl-zing team is deyelcp the draft as that we can with the expected deadline. Please give this FDA letter urgent pricrity. This letter is a clear indicaticn cf the FDA's ccncern with the sealed eleyatcr wire channel. it may be required DMEC tc develap new material tc supper-t the ta this letter- Please let me knew if ycu have any immediate. critical questians. Thahl-r ycu Laura VP, Regulatcryi?DIinical Affairs A Duality Assurance cf the Americas 35m] Diaraiarate Pathway Denter 1Halley ?lElD34 Fdrwarded by Laura an AM Fram'. DDRH Signal Management sCDF-tHSignalManagementrEfda gay?:- Tcr: "?Laura can't" {Laura starrns-lyle?elympua mm} Dc: "Simcne, Lisa" sLIsa Eirncnergfda gays. '"r'uslein. Arch {Area ~rustern?fda gay}, DDHH Signal Management agarnent?fda gaye- Date: D?idatzd?la AM Subject: request letter fram- regarding Medal taut! and related Dear Ms. Etarms?tyle ry Attached is a request far regarding Mcdel and related and a patential safety ccncern infecticns with ca rbapenem-resistant Enterclbacteriaceae falls-wing Ehqlangicdancreatdgradhy Please ccnfirm recelpt at this request within 3 business days and feel free ta ccntact me if ycu haye any questicns er cancerns related tc this request. Thanlr Tau. Lisa Lisa Simane, Signal Manager [an detail] foice at Suryeillance and Eticmetrics a? A Heem 2303 Email: lisaeimerler?lfdehhsg? [attachment leuerte deleted lav Laure StermafHOjCerprel] To: EXHIBIT 9 From: Sent: Thur 2/7/2013 5:27:47 PM 1172' 1'1 Importance: Normal Subject: Re: TJF-Q180V 8 Received: Thur 2/7/2013 5:27:47 PM Kazu - thank you. Earlier today I suggested to Donny that we get together as a group to review some of the questions that have been raised on this report and on the complaint investigation in general. Today is not a good day for this meeting due to the ISO audit. Perhaps a meeting can be set up for tomorrow. I will not be available but this should not prevent the meeting from occurring. Thanks Laura Eff?Hm if KERR Sent from my iPhone a On Feb 7, 2013, at 11:54 A . "Kazufumi Fukuda? .1 Hello Laura, I think that, he would like to say "for example, noise" and he means "noise" is bacteria coming from outside during culture testing etc. In other words, the scope had not had any bacteria after reprocessing, but was contaminated during, for example, culture testing. I have read the Nelson lab's test report and relevant emails, and the culture test result by the Nelson laboratory was negative, however the 2nd culture test was positive. I heard that we sent the Nelson laboratory the tube, the biopsy channel and the suction channel after disassembling for 2nd culture test. I am not sure Nelson lab's test protocol, but how we can rule out that the bacterium could come in to the scope during disassembly. There may be information that I don't know, so I will ask Connie detailed information. Regards, Kazu Fukuda Laura 05:31:16 Kazu Do you know what Mr. Nishina means below - noise". From: Laura Storms-Tyler/HQ/Corp/OAI Kazufumi Fukuda/West/Corp/OAI@OA1 Cc: Connie Tubera/West/Medical/OAI@OAI, Dave Barlow/HQ/Medical/OAI@OAI, Donny Mary Ann Mia Zhang/West/Corp/OAI@OAI Date: 02/07/2013 05:31 AM Subject: Re: TJF-Q180V Hi Kazu Do you know what Mr. Nishina means below - noise". Thanks Laura Sterms?"Ii?yler UR, Regulateryr'?linieai r?ttTairs Quality Assuranee t'lempus Carperatien ef the Amerieas Cerperate Parkway Center Valle PA 13034 Iaura.sterrn s-tylenfg'fgelymeu seem Eiusurnu ?5:5 I 123 AMn?Laura-san. 'l'hank yeu tier yeur reply- Ii re n1 Susnmu Hishina-?j 3 Te: Laura Strum len'l l'y'lI?US Ce: Cennie Day-e Barleyr ?mm? Hheki llisae Kaau?nni Fukudar Mary r?tnn I'Jresneeleil PEDAL Mia Date; I 3 {15:5l AM Subject: lie: iliT'y? Laura-sad, Thank yeu fer yeur reply. rind I appreciate yeur attending EPF meeting. I'm serty that my eemplea deseriptien might be eenfusing yeu. My standing peint I den't think that the eause ef the SUV eentarninated was insuffieient werkt I think that a faeter is in semewhere else. neise Beeause TIILQ ltl??y? ean he earried eut high [eye] disinfeetien by la the eurrent manual, - r?ts UPC-M reert indieate t'ellewing, It may he net Iikely that eause is insuffieient ?ltheugh seine suggestiens were neted by Mary Ann Dresneek te impreye their there was nething that was eensidered a majer risk l?aeter fer It?. prreumrmiete' transmissien. -Ne majer ehseryatiens were neted during the inspeetien et?the ERCP endeseepe in questien. The eause eferrntaminatien eeuld net he eenelusiyely determined just new. I weuld like me te tell the results el'the Ht} investigatien by HM. Regarding 333 Sinee DAI judged that MAJ-I333 is intreduetery needlessness, it is net seld in the United States. I think it is reasenahle. Chaeter 5 the Iindeseepe manual indieate the Fellewing. Brash the fereeps elevater and the fereeps eley'ater "El-rush the distal end eF the endeseepe eaeept the fereeps eleyater and the fereeps eieyater using the single use ehannel?epening eleaning hrush? until ne debris is ehseryed upen efthe hrush?' Susulnu Nishina Chief Manager ?lial nun-slit? Hminh?rnl?lnn l' Regulatery Affairs 3: Quality Assurance Department MEDICAL SYSTEMS CORP. E-rnail: This c-mail may centain centidential andfer privileged inferntatien. Il'yeu are net the intended recipient (er have received this e?mail in crrer} please netify the sender immediately and destrey this c?rnail. Any unantheriaed cepying, disclesure er distributien ef the material in this e-tnail is strictly ferbiddcn. Laura .?vlr. Nishina Thank yeu fer yenr respense. I am geing te feces right new enly en the Free I: Laura Etertns?Tyicn'l' lfijjt'JAl Susuntu fie.- An geiilta lunsalie" EndeffJFIi't? tiff-1H ytnpus-liure pa. llCennie ?l'uherai lff?DAi, Dave Denny Ilireftnni liirelti Hisae Mary Ann ernsneclzr'] IQ?dedicaifUAIE?Al, .?v?lia EDAI lime: 2f] 22: In EitIl'giect: Re: TI Eli?s" Dear Mr. hi ishina Thank yen fer yeur respense. I am geing te tecus right new enly en the UPth ceinplaint. [Eli'th has a meeting tenterrew merning, and has requested the Uiympus input en this celnplaint investigatien. Therefere - - Can yen please capiain hew UMSC reached the that insufficient reprecessing was the cause fer this Since UMSC was net en-sitc at and did net investigate this facility, hew is C'Sl?vlC reaching this Speci?cally what evidence dees UMSC have that supperts inadequate reprecessing by LIPMC. ?r?eu de net cite any ehjectivc findings, testing, etc. her this endescepc medel. This tact based analysis is required te snppert a cenclusien, and I de net see any analytical review efthis cetnplaint. - As yen knew frem reading eur MEIR, CA1 sent this endescepc te eur Inicrebielegy lab. has received a repeit fretn eur micrebielegy lab indicating pesitive cultures fer the which is the subject efcemplaint Cennie - Please send Mr. Nishina this repert. As per eur established cemplaint precedurey please fellew the reutc fer QIS cetnmunicatien en 2ft] 2 SJ 003427. Regards, Laura Stertns?Tyler EAR, Regulaternylinical Atlairs if: Quality Assurance Olympus Cerperatien efthc Americas ssee Cerperatc Parkway Center lv?alle PA 13034 Susuntu UT: i4235 Alvin-Dear Laura?san, i say seriy fer waiting regarding this issue. 5 From: Susumu Nishinalip/olympus@0LYMPUS To: Laura Cc: Dave Barlow/HQ/Medical/OAI@OAI, Hiroki Moriyama/jp/olympus@olympus, Hisao Yabe/jp/olympus@olympus, Angelika Mary Ann Drosnock/HQ/Medical/OAI@OAI, Donny Connie Mia Zhang/West/Corp/OAI@OAI, Kazufumi Fukuda/West/Corp/OAI@OAl, Hirofumi Ichimiya/jp/olympus@olympus Date: 02/06/2013 07:14 AM Subject: Dear Laura-san, I say sorry for waiting regarding this issue. By the result of checking record, This Quick Guide Created It was informed defore that this Quick Guide is related originally combination issue with the endoscope and ETD which is AER sold in Europa and not in the US. OMSC had checked that TJF-Q 180V can be carried out high level disinfection by reprocess according to the current manual, Regarding two MDRs related to the contamination considered that TJF-Q 180V might be involved in US, we did risk assessment. Result Acceptable 2 Severity level I Srious Probability of occurrence Remote Now transrating the risk assessment table recommended to use the cleaning brush MAJ-1888 in the cases of heavy soil or delayed reprocessing. - 80V can be carried out High level disinfection without MAJ-1888. In order that OEH may obtain mental relief further, Single Use Soft Brush MAJ -l 888 was demanded, and MAJ -l 888 is written in the reprocess manual for OEH markets. >this Guide further clari?es that the forceps should be raised to a 45 degree angle, whereas the Reprocessing Manual simply refers to an indeterminate position. - The Guide which OEH created is not in agreement with the reprocess manual for OEH markets. The manual for OEH indicated as "approximately 45 degrees?, and it is not necessary to be "j ust 45 degrees?. Supplement The reprocess manual for OAI market indicate that forceps is raised half before putting TJF-Q180V also into AER. The manual for the bouth(OAl and OEH markets) for 160?s scops was not indicated forceps raised. >Regarding a similar complaint with UPMC - According to UPMC meeting report, I think it is not likely that the cause ofa similar complaint of patient infection associated with the TGF-Q180V was insufficient CDS work. there is no evidence. >ls OMSC going to revise their Reprocessing Manual to re?ect the recommendations found in OEH's Quick Reference Guide? - OMSC is not going to revise the Reprocessing Manual >Should 0A1 also be communicating to our users the information that OEH is communicating to their _l .- Eurttpean users? - Altheugh it is net need te eammunieate te all the users aetiyely, yeu shnuld eemmunieate with the user when has asked a questient Beeause risk assessment ind ieate have questiens+ I . . Have the ERCPseepe efthe Miehigan QIS {t3 Z?l? - SJ [ll-3342?) been returned baelt tnte SJ and then tnyestrgated?:I Dese SJ see samething Sincerely yeurs _r_r_r_r_r_r_r Susumu Hishina Chief Manager Market lQuality Administratiun Regulatery Affairs d: Quality Assuranee Department ULYMPUS MEDICAL SYSTEMS CURP. E?mail: susurrtu This e?mail may euntain een?dentia] andr'er priyileged inferntatien. Ifyau are net the intended reeipient {er haye this e-rnail in errer) please netin the sender immediately and destrey this e-mail. Any unauthartaed eepying, diselesure ar distributian efthe material in this e-mail is strietly l?ttruartietl lirurn: husumu l'ttmt'rl'tivi?d Hate: {Hz-ll} Laura Tn: Susumu Nishinaijpiulympus-?JDL?t?MP Ce: Dave Hirulti Hisae Taber?jp?elympus-?ulympus. pus-Eurapa, Mary Ann Dresnuel-JI Denny Sh?ptl'?lfl IQr?Eerpf?rsIgj-Dr?tl: Fannie 'l'ube Mia Kazufumi Date: DHIH Suhjeet: S?lu? 1' I -P Dear Nishina?san 0A1 has reyiewed the Quiek Referenee Guide that UEII is using ta send te their eustamer in the Netherlands I requested eur mierebielegist ta leak at this Guide. The differenee between the quielt reference guide and the Ql Ell-V Manual is the reeammendatien ta use the eleaning brush MAJ-1333. in the eases at heavy sail ar delayed beeause it allews deeper inte the fareeps eleyatnr. Additianally, this Guide further elarifies that the fareeps sheuld be raised ta a 45 degree angle} whereas the Reprueessing Manual simply refers ta an indeterminate pesitiun. 3" ii Susumu Nishinaljptelympus babe] rut Please be aware that am submitted a MEIR en a similar eemplaint at" patient infeetian asseeiated with the Tatar? any! leap r-n'n't: nF MHE F?nll?l??dd?? belnw. See attaehed reaert frem eur en?stte 7P JL repurtrluc" Susumu Nishiuafjpfalympus i it] 1" JL isms?slams] 313532?.pdf" u: Susuutu Nishinafjpfulympus ass as a it] My quastiuus arc as fulluws: - Is DMSC guiug tu raise their chrusassiug Manual tu I'a?aat the racummaudatiuus in Quick Guide? I I I - Shuulrl um alsu ha camrnunisatiug ta uur users infurmatiun that UEH 1s summumsatmg ta thalr Eurapaau users? ngards, Laura Laura Stuarts-Tyler 13.13., Ragulaturyr?Cliuisal Affairs ?5 Quality,I Assurance ?lympus Curpuratiuu ufthc Amsricas 35W Curpurata Parkway Canter Vallsi PA IBM-4 1aura.sl urrn um r: scum Laura Eturma?-Im?u rpF?M Ta- rrnar?mr 11115 HIM Rick ra radian Hr Jam-r1 Ta Lu ha Marl-L Philip Hiahard ?air-u:- Ha Earl Firnahi Pita: Enlarge-at Re. Fw. TJF-EH Hi Rica: - I ta mark with Markelrng and Mark ta davahap a aratarnam Ihat wa can prawda a5 raquirad. Drhamiaa._L_ gin wanking aatraeiy my [was an Ihrsw ?un't Iran Il' thra- a nswera: your quaa?an- hurl-lever. please led me knaw. Thanks Laura Starn'na EFL Regulataryf?liniaal A?aira. En ?uallty Aaaumnae ?lympua Garparatian af tha Amaricaa 35m Carparala Parkway Eantar 'I-r'allai PA 1 503:1. iaura n-?r Risk Farhua?i?anhlh?hdim??hl - Laura .1. John Harnerf??lhledical-HMEUAL .lnhn luka Mark Philia Daylaans?aaia?mNgg??I.Richard Eairua MauhidalH?Ma-?laar??f??m. Ear?l Adamyr?anlralrr?edic-HI?UMEDM. Hfrashi Mma? Eur-:5: Didi AM 51-. it-jE :1 Ha: Fur. Laura. It appears this "nay put Extrema [Jr-assure an Olympus. la plaarirla paliitufarly in 1'ghl the Mile! being drarributa-d in Europa. Tnia alaa rapmaama a 9 Eat appanunaty far our ET dad-tea an I am aagar ta mava ahaad ASAP. mum agar keratin mam:- r'nra {In gnu raquira far us. as narrt Sta p5? I'w addid Earl and Ari ta this distrin ?an liar. Hagards. Flick Ha rhucl-r Era-.4: Vraa Preaidant Elmaran Ulympua Puma-nun Inc. 35:10 Entar PA ram-1 I [TILT-Hughes M41115 {43-4} BEE-T1 21 richherhucltt?ulympusxdm meweiympuee mend: -cem 'hi Title and any :11: ehed ?le e. is: intended eehr fer the sale ef the in ditridual er enlity te which It is. addressed, and may enntain inlennetien that is privileged, dentidantiel and exempt tram dieeideure urtdel applicable law- If yeu ere net the intended mcipiint yet: are net euthanized te read. print. retain. early. distribute Dr dis??n?n?f? mass-HEB er any part ef it. If fill: have received this message In errer- netih.I the sender irnrne dieter by e-rnelt and delete an eepiee cf the message. Laure EtermaHQFCer-es'tthl Ftieit URI .ie-hn Hemey?titl?edeeah'?mg?hl. Jehn Luke Mark Miten'H Philip Richard Selma Eute- D5221 Mai Sen}: Re: Fw. TJF-G Ftieh - Actually, the Get 1 is net enly the eheelute beet date but GMSC ie under a great deal of stress tn edtieve this deadline IF we get chetlengee frem the FDA en eur test meltinds during our prdauhm "55-an HHS Elite may silli- Regard; Laura Etienne UP Regulateryrf?iir?cal A?aire 3L Qualityr Assurance Citympus Enrpuraiie-n er the Ahtetiead 35m Parkway PA 15334 Rhett Lauri Jehn Hen-new: :u?dedieemmg?m. Jehn Luiti Maui-i H?mII-r?imldiettr?hl? GAL Ftir: he'd dame MichidaIH?IHu-dica 1: - Ill-9:15 Ah! Re: Fuel: TJF mew Laura: H-ew meld we euhrrtit 500nm 'iI'u'llh Gurueei ie te submit the new 51th. by ?eteber 1 2014 Regal-d5, Rick HII?b-Llcit Greup President Endempy Dittieth ?fympue America Inc- 3501] Emperele Parkway Center 'Iu'iiley PA 15034 Fee {454} ESE-T1 21 tiek.harbuck@elympue.eem uwwniympui?me tic-Idem This and any attached tllee. is intended enty fer the eele use at the er emit}.I te which It is ELY-Hughes. Unit 1746 eddre seed, and may dentein I'I'IIfem'Ielier'I lhel is privileged, sunlid-entiel end exempl item disclesurl under applicable law If see are ml the inlend ed resipienL yeu are net eulhenzed le reed. plinl, retain, cepy. dislnbute erdisseminele Ih'rs message er any ef ii. If yeu renewed lhis message in errer. please nelify the sender immedislely by e?n'lell and dslels ell eepies sf 'H'll' n'Ie ssege- Liter: is. .'ehn Templer'l-l Hick Hamuslrf-Cenfml??edissl?m??m. Richard Lul-re Celerafle?-?dseisel?hl?-?hl. Merl: Slime Hamid-:1 Hers: Wrasse? tigers-sf: Fw: Dear All - I em sharing Eurepe regerdmg resent Euslemer leerrs en 1hr: duedeneseepe. DEKG fs en resell {referred le beiew se a - Field Halide] en the The eerre eli're sslfen is the prdmelien sf 3 smaller bristle brush for brushing sreund the recessed space in We TJF's distal tip. This smells: bristle an-sh is else intended in be made available in ?re U.5.. he1ers'rer.ws are walking with lhe FDA en life test mell?Ie-ds 1e eseiuele eur represessing velidelien lend efh-er feeling}. Eddilienelly. we will need is eleer ?lm: en the revised I rnefheds wi?r Ihe smaller bristle brush. es this defies eel be available fer while. Uur deal is is eubmrl the by Usfebe? 3114. fuler - ?fer-neg :enjuneher. with er'd Jehn I weuld like ts eensu In deletn?ins sirEIegy d- slammenf lslfer helh Eel-es :Inr. Eustemers is the were this irfem1s1in'1 hes-:rnes knew-1 In the LI Thanks Lsure Laure Slerms Flegulstenr?linisei ?lfeirs If. Dmli'qr Assure nee U?mpus Cerperalien ef the ?rmness seen Cemente- Perl-may center Willi! fees-If Iewestem'is?ehmpussern mrardiadi by Laura: er'l Girl: 5201-1- All Angelica Lsum User: 92:34 My! 15:. sir. HI Leure IElm: week heel-r frem my summer helidelr. The week began 1I.rer1Ir quite and wilh 111s anneuneementef lhe resell In Japan I am new fully been Ceneerning the the sites lien is es felines: In Essier :1 Iii. IL Lu .elLil. -Iii'i?: - -I .I Jim-3 ilIi'nIJIeI rl{air-I'M" r'll 1'rl_ .- I ItII. new. .- rah In .. I-I. ..I ?511.. ..I I Elm-i. J--u Jllerlui i.--I1 -: .'1Il. I I I "IraBLT?Hughes M41141- :1 (In ilIr-I' n: 'rII'li/tfr- I i I vl {Urn}. freundtichen Grurlen - Best regards Angelika OLY-Hughes 0041748 QFYMEUS Jessie? 33332.11, 4 Your Vision, Our Future For Group Internal Use Only FDA Audit! Inspection Minutes FDA Auditor(s): Brian Keefer, Investigator Olympus Audit Leads: Laura Storms: VP, OAI Tara McBrearty: Directory, Field Service at TAC, MSG Steve Thomas, Sr. Analyst, War Room Personnel: Alicia Hayden (AH): Daphne Germaln~Kolawole (DG): Erich Lukas (EL): Cathy Riley (CR) Joe Osika (JO): Coordinator Connie Tubera John Kershesky (JK): Robert W0jcik (RW) John Nienstedt (1N): Scribe 2 Noemi Schambach Mike Jackson (MJ): Scribe 1 Christine Phatax (CP) Sherri Musgnung (SM): Rob Cermak (RC) Stewart McPherson (SMM): Zach Brisson (ZB): Inspection Date, Time and Location: ApriE 1, 2015; 03-2 Audit Room; 03-3 War Room, Center Valley, PA Time Stamp Initials Discussionls) Completed? 00:30:15: Ereparations in progress. Allonstangby; 11:11:01 FDA Arrival announced. Participants en route to 03?2. 11:19:22 JN investigator arrives in D3-2. 11:20:13 4 JN No additional documents will need to be pulled for this week. 11:20:41 1N List of participants requested (in audit room, Laura, Cesar, Tara and Steve) 11:20:51 . JN Investigator mention of 510(k) product from 1994 11:21:00 JN Listofall products serviced by Olympus 11:21:53 JN Investigator mention of PF 8 from 1994? Requested clarification. 11:54 11:23:40 JN Laura Storms describing responses to complaint from Europe. FDA became 11:23 aware of complaint, and asked Olympus for information regarding the . complaint, which was provided by Olympus. 11:25:43 i JN Laura Storms describes complaints against duodenoscope discussions at MA I management review meetings. Issues were raised to Senior Management regarding adverse event trending. 01 July 2014, Olympus responded to letter from (center), Dr. Yustein. Since October 2013. Olympus has been engaged in discussion or engaged with manufacturer. Olympus has been responsive regarding this I issue. 11:28:06 JN Request for outputs from Management Reviews related to duodenoscopes. 11:31 Storms to present portions of Management Reviews that related to this matter. 11:28:47 i JN Request for July 2014 letter to Yustein. 11:29:36 JN October 2014 telecon between Olympus Japan and FDA. Request for minutes . 11:30:01 2 JN Was there a CAPA opened? L. Storms states that CAPA 131 has since been 12:17 opened. CAPA describes customer letter to all consignees. 5234511.? OLY-Hughes 0013965 OLYMPUS Your Vision, Our Future For Group Internal Use Only Time Stamp Initials Discusgignls) Completed? 11:31:03 JN Request for CAPA 131 file. 11:31:26 JN L. Storms presents pertinent sectionls) management review from 11 October 11:31 2013. Was discussed with executive management Request for 31 October 2013 letter to Louis from Olympus America. __11:33:07 1N Request for initial AI letter from FDA (da_ted 16 September 2013) 11:41 11:33:35 JN L. Storms presents pertinent sectionls] of Management Review, held on 10 11:33 i November 2014. 11:35:48 Question regarding attendees from Inspector. L. Storms indicates that it is 11:35 executive management from both San Jose and Center Valley locations. 11:37:54 JN Was there any additional response from FDA following the Al letter? L. Storms: 11:37 I. no. 11:41: 15 JN Inspector is reviewing Al letter from FDA. 11:41 11:45:22 JN Inspector inquiring about life expectancy of scopes in the ?eld. L. Storms 11:45 I estimates that it is 10-15 years. but mentions that it is speci?ed by OMSC. 11:48:33 Storms presenting list of models serviced by Olympus. 11:48 11:49:33 1N Con?rm whether PF BP is still being serviced by Olympus [under investigation 11:54 I bySanJosei. _y 11:51:55 1N Question regarding the soils being challenged enough. L. Storms describes that 11:51 the FDA requested Olympus to share reprocessing methods. FDA challenged Olympus to make the reprocessing methods more enhanced. Olympus complied. 11:54:26 JN PF-BP was no longer serviced as of 2010. 11:54 113552.36. 111' .. PESrases" 11:57:21 i JN L. Storms describes that Izu has been previouslyinspect-edby-FOATM 11:58:24 JN D0 certain facilities have testing processes for microbes. L. Storms has 11:58 interacted with the CDC, sharing our processes. Olympus is familiar with CDC microbial testing protocols. We are members of AAML Our resident microbiologist, sits in on meetings (standards committees). Our 12:01:55 JN 09 May 2014 letterifrom Dr. Yust_ein_(L Sto_rrn_s) 12:15 12:03:52 JN Initial letterthat was issued? 12:04:15 L. Storms presents letter that was discussed in October 2013 management 12:04 review. Also presenting letter from 2014 management review. November 2014. we again discussed duodenoscope processing. 12:05:00 JN Letter from center date 09 May 2014, and Olympus Response from 09 June 12:05 2014. 12:05:56 JN Management review of November 2014,?tuhat we had been I 12:05 communication with the parent company in Japan ad that we were working to mitigate risk. in October 2014, we were meeting w/the FDA, and there were I members from Japan in this meeting as well. The topic of duodenoscopes was also covered, and how we can mitigate the risks associated with infection from - Duodenoscopes. 12:09:47 JN 09 May 2014 letter is being printed and prepared for distribution to Audit . Room. 12:12:06 JN Did the FDA request additional information regarding scopes outside L. 12:12 OLY-Hughes 0013966 OLYMPUS Your Vision, Our Future For Group Internal Use Only Discussinnisi ?Eomplelteng? Storms stated that the letter in question referred to the Netherlands. 12:13:20 JN L. Storms discusses general article regarding non-Olympus duodenoscopes, 12:13 I at a hospital in Illinois and an outbreak. 12:15:17 i JN L. Storms presents letter from Dr. Yustei from 09 May 2013. 12:15 12:17:00 I Storms indicates that still awaiting AI letter for Louis. 12:17:29 JN Reviewing CAPA 131. FDA recommends that we make our reprocessing 12:17 methods public. New brush and new cleaning methods will be available in May. In the meantime, they should use new reprocessing methods, which are part of 510 application. Early March, FDA asked Olympus to release the methods early, prior to 510 release, to allow customers to begin using these new methods right away. 12:20:09 JN Has the Japanese mfr. Opened CAPAs over this 2-3 year period? L. Storms: 12:20 I Yes, and they are referenced in the documentation shown by Storms. 12:21:27 I JN Request for copy of revised reprocessing manual that was part of 510 submission. 12:21:46 JN Inspector does not believe there is anything additional needed. More speci?c questions will be asked of OMSC during the FDA visit scheduled for April 2015. 12:23:11 1N Inspector will write a report, submit to CDRH, and provide a copy to Olympus. MA I No observations or ?ndings. 12:24:05 3 JN L. Storms and front?room attendees describe their roles and functions within 12:24 Olympus, per request of Inspector. 12:25:50 JN All US recalls are initiated in Center Valley of?ce, confirmed by L. Storms 12:26 12:26:32 JN What is the highest role in the San Jose facility? Director, is the 12:26 highest-level quaiity assurance role in San Jose, per L. Storms. 12:28:29 - JN Organizational chart, demonstrating L. Storms reports (in (N and SJ). 12:49 12:28:57 IN T. McBrearty describes role and functions within Olympus. 12:28 12:30:18 IN S- Thomas describes role and functions within Olympus. 12:30 12:32:03 JN I Business hours? 07:00- 20:00, M-F (service). 09:00 17:00. 12:32 1234-?24 . IN My guesses fer. pessimism Olvn?i 12:34:43 JN L.Storms: This was a directed inspection. inspector con?rms that the NM manufacturer inspection will be critical. 12:36:15 JN L. Storms provided a list of MDRs to from the Philadelphia of?ce, and sent NIA hard copies of MDRs on Monday [30 March). 12:40:04 JN No other questions from L. Storms. 12:45:00 JN Suspended for break; I 12:49:23 JN Resuming 12:49:55 i JN Reviewing Organizational Charts w/L. Storms. Describing Dr. Yustein?s group, 12:49 and other teams within Olympus. 12:54:45 JN Storms presenting 16 September 2013 letter to investigator. 12:54 12:55:22 i JN Closing down call. To add a new Discussion point, click within the last row, last column above and hit the TAB key OLY-Hughes 0013967 OLYMPUS Yamagaf?i?rrmure For Group Internal Use Only ACHDNED: (Include datesfordel and Ag?gn'ltem .. . .. I . DueDate new Action Item, click within the last row, last column above and hit the TAB key Do time decisions or proposed activities require additional review by one or more of the identified groups? if so, identify action item for discussing/meeting with member of identi?ed group. Additional Review: I Legal Human Resources Compliance PR/lntemal Comm. Product Marketing Finance Other OLY-Hughes 0013968 (:31 Dlm'Etl'E?tE was an T3 Hiretti Hisae Iehlre Math. Maeae ?r?an? Elsarnu Hehaya Susunm Hishinafjpfelympusl?etynpus. Tatayasu ?r'eshitate Eater: Math tic-r: Subject Fte: IDEA fer [tear Tashtre?san thanI-t yeu fer preyiding these draft tie-As. 1 hepe that DIME: will tsunami the feltewing as fer yeur Baths. yeu may remember frern ear meeting with Ill-h en Dee. tElh. FEM. desenhed their Safety Alert as fellews: Safety Alert we uld he a summary at the prehtern with a diseussien ef the eemplaints. with a feetrs en euthreairs ef 'rlfeetiens but wil net identify any pa rtieular manufaeturer. The alert will disease the seeps design as prebternatie. and rete tense ereyieea that eannet be brushed- .ft high level generai disc-u ssien will be based en best practises en instrueliens and Cluelin Bertth Fregra n1. Teeterday, I a call heal: frem AGA's Etteeutiye Management asl had earlier called them In share eur draft Custemer Letter. lilil'nile I was en the phene with the ABA. they een?nned ABA had FDA's draft Safety Aland fer review with eernments due haeit Ie FDA by this Friday- asked ABA if the aheye desenplien ef the Safety Alert was eerreet ALGA een?n-nad that this daseripiien is accurate- the reasen I am sharing er reminding et this infe rrnatien is te matte DMSE. ready fer a FDA Elal'ety Merl whieh is tilter te discuss F?i?n's eeneent with deedeneseepe device design. I we trid net he surprised If FDA states in title Safety Alert that seen if the seep-e is eerreetly. there is still a risk el' infectien eased uper'r preduet design- I anticipate we eeuld see Fllh's Safety Alert neat weelr. Finally, as yeu ttr-ew, FDA said they will revise eur draft Eluslernsr Latter enee they haye ?nalized their Safely Alert. Therefere. we else need Is he prepared Ie censidar input en eur latte r. I weuid rrel he surprised it FDA aelte us te add language aheut ehallenges in brushing the ereyiees. I wiil of tenure: eertlt'nue le keep yeu inl'ermed. Please let me knew if yeu have any quesiens. Thanlt yeu Kind regards Laura Stern'ie Hegulatererlinieal Affairs a. l:lualily Assurance Gerperalten ef the Amerieae ssee Cerperata Parleway Center 1y'all PA 13034 Ia Frame. . . . Mame-lug re.- Ct: Harte Taht?pl?wnpus?'uiympus. ?t'eshilalte Eaitei'ip'elyu'pus?elympua. Taluyaau hflyagi'pfeiynmue. Iehire Hirele Hertyarna?pr'ehmws?etyrreus. ?samu Kelsey: ELY-Hughes 000199? Masao Yamaohaliplolympu?olympus. Mark Susumu Date: Subjecl' on for media Laura-sen, In preparing for the coming news release of USA Today, for your reference. I am sanding you (Tiger Team in ON) a dralt QE-A which was generated by OMSC to be prepared for a Safety Advisory Notice which FDA Ins been planing to issue. OMSC drafted this QM intending mainly for the communication to Japanese media. 0113 of the main objectives of this 0% is to guide our stakeholders eppropriatety understand FDA notice as a limited impact to Oiympus business. wound like to share this GM with your Tiger Team include Mark Milla r-san in 00A incharge of a public relations. If you have any comment. please let me know. [attachment deleted by Laura StorrnsiHQlCorpIOAl] OLY-Hughes 0001998 EXHIBIT ?3 1 1112:1111. MES Llu? ElmMEFDurP-i??l Tn- 1'1: 0' 112111121115 111-29 111.1 SE - Danny {21:11 11in Kabuki Hirn'ki l?uriy'nrm?p'ulympusgulmus. Hun'rrm? Tanugudzi'wulymuguhrmpus. 51.1mm Hum-111 Ethan-111:1: b5: 51.111ch He: I'ar Pa?ent lnfeut'nn Spraadshaet?? M433 Ulnar Whip-5m - I am gu'ng In send 11:11.1 Iain: 1:111:31 ?nm FDA. an 1:11.11 draft Dear (31.15111 mer latte r- I agru- I22I~I:1nr111r that Ihasa MERE shank! he ?led agains'l the 3W In an abundance nau?un ralame 11:: saluting 1h: warrant mus-dual. Hagards. Etc-rm: Hegutataw?llric-ut Affairs. 11. [11.13113 Olympus Burp-1:1 mlinn 111? the Marinas 351:1: Cmpumla Parkway '5an H'allei FA 134334- Iaurl slums?ulynpusmm Frnr-1 Hi5: Tn Dunn . fir: CM. HEhhuIm Lauri rp-F??l??hl. HiTuki Hminurl Sui-uni: Nomi Dam: DENIJEME 1111:14- PM 9.1.111]: HI: MEI-H's. far Patient inmadih?l Dnar Dun 1131-11311. WE hnu-w mm .J BEN and previous dumlhnu 51mph have the elevator channel (HF-CIT BEN may nul hi5], the IDWBFIE ulna-11111111 and parts which i5 111:1 13111511 In: am as and clean 111a naughty. I 11:11:11 I111:1ur Ella-1:151:11. DAI 5111111111! :11 far. It shuul'd ha cumhdad at 6115 1.151111 rman [5 1.111an but 1hh1'11 '15 5111351 11111151 11f B?'lul'. Burst Regards. Hiram ?r'aba Chief 1211511111 In'qamwn'r?nt 1:111:11 Division Manager {Ini??ly' I]an HEDICAL CERF. 1313311151111 This E-I'nall may mnlain mn?dan?al and?nr privilagad info'rruliun If you ara than inlindnd recipient [or have ruthlin this a-mail in anal} please I'llil?ljl' Ihs 's-E?dEl immediately and deslmy this E-mal Any unautlmiand Gaming. diicluiur? ?r distrihu?nn in this a mail i: Strictly forbid-d5 n. Danny Ta: I-llaan cg; gal-Imp: Tu mum-cc Lljjicmlinsu :nm??lg?hl?. L: urn Sinrma?H?'?n Hunk: I-iuninmrl Euaumu anml Gall ?ctc: 2m ?33.15 Baht-5 : Far Putin nr. Infectinn Dear Ya be?nn. Please sen my responses In ynur quealinna belnw. Please let ma know If you have any Regards. Danny Shapirn Diractnr. FEMDA Db-mpua of inn Americas Madical Systams GruIJp 2400 Hingwnad Aura- San Jase, CA 95131 "lL'i?G Ta: Dunn? Ct: Danni: Kiliaqu Li ura Hmki Emu-1 Emumu Hismna?mmua?nlwui. hu-In'u mmram? F'I'ul air-1t at Fla: [or Infulinn SPHI-dih?l Dear Danny-an. I have mama qua slim-n5 11 Did DAI dabanninad uaad modal anly Tram LISA Haws :Ir infarmatinn irurn In discussinna mm mm?: an Augml E1114 they ata ted the! II. was specific. in a1mInr mannal design LIL-1A. Tad-33". and anther articles an: quntEd as saying 'anrne parla ui' H15 saunas may he dillinull tn amass and cumin VMMC has a high number of 5W. As gnu are swam, i'rIpIJinatin-na are ardLIIrId than dusign Elf Eh: fund-apa- :Ie?u'alu r. 2} Ican'l. ?nd nut such deacriptinn iniha new-a- in tn: new did CIAI .5101 The Vidal} in H1: haginning of ?nish describes it as mil as the 1man in than adiala: Hera is analhlr artich- fr-nrn lhE Saar?! Tith Mid-I rafarannes tha REV design: mn?h?nl?uc?lnaw??i 3} VHF-15 Ell-U Ina-ad I'm all til 31'" nan-5? Whal the We dc- nonchmuelr iFaI cases used this a nd hava bean able gal." additinnal Flam VMMG. how'E'HEl hand an an the additinnal inFurrnaliun I'll have ahtiined. lhl'i is Iha mulls! likely Hamlin. Best Hagard?. Ii lint-Ii til-I Ila-Hil'lnll {SILT-Hughes [#030601 Hisae ?fahe Chief ?nality:I ln'pretrernent Diuisten Mini-gar Quaity a. Enuimnme ht Divilldn ETETEMS SCI-RP This u-rnail may eentain enn?dantiad andlerpiiuilagad inferma?un. If yeu ara net the intended racipiant [er have received this I-maii in errer} please notify the sender immediater and dailmy this e-mai- Any unautl'ierized damning. diselesure er dietrlhutlen n+me metedal in This e-rnaii le elrietly lerbidden. FW Elenrw Te: I-heae TubethaWadieeli?Al??m, Heieulua Laura Stemmit?l?r?erp?hl??m. Hirelti Methane-welmua?erywie. Stem-in Her?nefw?hmpue?elympue. hide-mi Ethan'lhaeh?iu'cm??lg?? Date- W13 sealant; Re: Hall's. {at Patient Infectien Spreads-heel Dear Table-San. ?fee, we made that deter-11in alien base-d en the USA tmtag.r arlieie where the new infarmetien netee that VMME discussed the patient Medians relates te ecupes. We have tiled aupplemente?. l'ulDFl's ti: een'eet thie. ?Bunnie. lilliarmzir Ehapim Direcldr. RAE-DA Cemera?en el? the Amalie? Hec?dal Systems Gmup 14nd Regarded Ave- San Jdee, CA 95131 Hind lzr. Denny.r Cc: Gentile Hamill: UIHDWUHQDM. Laura leeln Hunimerl ??lwl?nwt Enema Date: 1131 Nut 3;:tuicet: Ha: liar Patient Inf-ee?en Spinach-heel: Dear Denny-?n. Thar-1:. yeti fur the inlerrm'den- ?lls: will dwelt il UMEE: ltnewe all MEIR: Attached is. {misc I?lW?l?lili?n en the TJF-??l?iu' at ttia mement. [attachment dieweeidne en TJF-EI1EIZW ?ex" deleted by Danny Shapime rpi??'?tll Ema question an in my underetanding. mdel iypel?le} el' used duedeneempa is mknewh. Did eenfrm the medel typells} and Submit supplemental MDH: Best Regards. Hiaae ?t'abe Chief mality n1th manager Clea ?y I. Envirenment Dirie'nn MEDICAL Cum-Hughes cm were - I I - I This may contain mn?denliil :ndlm lelE?Ed inlurmatlun. If ynu are net the intandF-d recipicpt [ur_have rade this urn-rail in mm} plans: nulil?y the sand" immediately and d?ll'?jl' H'lii I-mnl. My unauthn-nzad dl'EDtEl-Ellfi nr dislrih-u?nn uFlJ'I-a nuta?al in rhia t-mail is shinny turbiddun- F?G't'l: Danny Eupirm'll?mnrpi?mwt 1. a: Hlsau Cc: aura Klimt?: (tannin Lilac. W?'l Suh'gcl: LID-H's Eur Patient Infantian Ema-await! Tabla-San. in an. allurt to keep hilly inlarmad and aware at aswcialnd with patient we: have maintain-ed than fulluwing spreadsheet and wautd like tn share with yuu- W: will update: with any narw ur mmplainls. [attacth "Gross. ?eletad by D?l?i?i?j? Eh npimlHlIllep??JH] Baal regarda, Danny Ehapim Elimdm. Carparnllun at ?u Emma: Medical System:- Emup 241M Ringwand Ave. San Jase. CA 95131 luglles