Events

Device Recall PKG, ROTATING HANDLE, RATCHET, INSULATED/SHAFT 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Endoscopy 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    69838
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0623-2015
  • 사례 시작날짜
    2014-11-17
  • 사례 출판 날짜
    2014-12-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-07-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131643
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Endoscope and/or accessories - Product Code KOG
  • 원인
    The parameters provided in the laparoscopic manual instruments instructions for use (ifu 1000-401-070 revision g or prior) do not support the unwrapped gravity cycle and the ethylene oxide cycle sterilization methods.
  • 조치
    Stryker Endoscopy sent an Urgent Device Correction letter dated November 17, 2014, to affected customers. The letter informed the customers of the potential hazards and actions required. Customers were instructed to discard any old Instructions for Use for their Laparoscopic Manual Instruments and Accessories. Download the new Instuctions for Use (IFU1000-401-070 Revision J) from the URL link below: www.stryker.com/IFU1000401070 Customers were instructed to complete and sign the enclosed "Acknowledgement of Receipt" form and email them to endorecall@stryker.com or fax to (408) 855-6314. Customers with questions were instructed to contact Stryker Endoscopy at 408-855-6238 or via email at endorecall@stryker.com. For questions regarding this recall call 408-754-2000.

Device

Device Recall PKG, ROTATING HANDLE, RATCHET, INSULATED/SHAFT
  • 모델명 / 제조번호(시리얼번호)
    42358 42361 44292 44306 102110 1092012 123010 140323 140337 0200294C 2092012 2172014 0245175C 0245377C 0245381C 0245820C 0245821C 0245832C 0245891C 0246317C 0246318C 0246930C 0247039C 0247041C 3122014 0341227C 0341901C 0344750C 04192012E 04232013E 42499 04262013D 0442448C 0442451C 0442454C 0442457C 0442458C 0442460C 0442463C 0442465C 0442466C 0442467C 0442470D 05102011E 5132010 5262010 0541369D 0541374D 0541377D 0541381D 0541388D 0541390D 0541392D 0541393D 6022014 6142014 06182012E 6202014 6222014 6232014 0640125D 0640129D 0640131D 0640132D 0640133D 0640135D 0640137D 0640138D 0640140D 0640141D 0640146D 0640906D 0643123D 0643124D 0643125D 0643126D 0643127D 0643128D 0643130D 0643131D 0643134D 0643135D 0643136D 0643137D 0643138D 0643139D 0643140D 0646331D 0646997D 646998 0646998D 0646999D 0647000D 0647001D 0647002D 0647004D 0647006D 0647008D 0647009D 0647010D 0647012D 0647014D 0647015D 0647016D 0647018D 0647019D 0647020D 0647021D 0647023D 0647024D 0647025D 0647026D 0647027D 0647028D 0647029D 0647031D 0647032D 0647034D 0647035D 0647036D 0647037D 06CON02507 7012010 07022013D 07032013D 7072014 0747491D 8152014 8182010 8272014 0840681D 0845166D 0845167D 0845171D 0845173D 0845176D 0845179D 0845184D 0845185D 0845186D 0845189D 0845190D 0845192D 0845197D 0845198D 0845205D 0845207D 0845208D 0845212D 0845213D 0845215D 0845217D 0845222D 0845223D 0845225D 0845231D 0845233D 0845234D 0845238D 9052014 9282010 09292010A 0940590D 0943416D 0943549D 0943561D 0943562D 0943565D 0943568D 0943569D 0943571D 0943574D 0943576D 0943577D 0943580D 0943581D 0943588D 0943590D 0943591D 0943597D 0943599D 0943602D 0943606D 0943608D 0943611D 0944130D 0944143D 0944147D 0944204D 0944205D 0944206D 0944814D 0945234D 0945885D 945996 1022031E 10302013 1040253D 1040283D 1042096D 1042235D 1042236D 1042505D 1042507D 1042508D 1043577D 1046167D 1046840D 1046842D 1046844D 1046845D 1046847D 11132013 1140932D 1141738D 1141740D 1142235D 1142236D 1142237D 1142637D 1142638D 1142639D 1143098D 1143099D 1143448D 1143450D 1143451D 1145110D 1145840D 1145841D 1146122D 1146200D 1146400D 1146401D 1146402D 1146403D 1146575D 1146576D 1146709D 1146710D 1147022D 1147155D 1147156D 1147157D 1147158D 11475155D 12052012E 1240573D 1240574 1240574D 1241089 1241091 1241092D 1241093 1241093D 1241094 1241094D 1241095D 1241096D 1242149D 1242150D 1242151D 1242152D 1242153D 1242262 1242262D 1242263 1242263D 1242264 1242404 1242405 1242407 1243936 1245526 1245526D 1245527 1245528 1245529 1246181 1246181D 1246182 1246183 1246183D 131299 1340503 1340503D 1340504 1340504D 1340505 1340506 1340707 1340707D 1340708 1340708D 1340709 1340709D 1341255 1341255D 1341441 1341442 1341443 1341443D 1341444 1341444D 1341445 1341445D 1341446 1341724 1341725 1341726 1341840 1341841 1341843 1341843D 1341845 1341845D 1341846 1341848 1341850 1341850D 1341852 1344137 1344138 1344139 1344140 391296 502498 502499
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
  • 제품 설명
    PKG, ROTATING HANDLE, RATCHET, INSULATED/SHAFT, P/N 0250080233. || Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life. || Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
  • Manufacturer
    Stryker Endoscopy

Manufacturer

Stryker Endoscopy
  • 제조사 주소
    Stryker Endoscopy, 5900 Optical Ct, San Jose CA 95138-1400
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA