Device Recall PKG, 10MM PEEK MONOPOLAR HANDLE 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-0721-2015
  • 사례 시작날짜
    2014-11-17
  • 사례 출판 날짜
    2014-12-12
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2015-07-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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

  • 모델명 / 제조번호(시리얼번호)
    42167 42169 42172 43238 43239 81309 142647 143476 143477 245841 342652 344115 345130 0442468C 0445112D 0541360D 0541361D 0641114D 0641115D 0644773D 0645377D 0647994D 06CON06071 06CON06126 07022013E 0740507D 0740834D 0741766D 0742442D 0742740D 0744063D 0744684D 0745499D 0746059D 0746497D 0747592D 0840357D 0840678D 0841358D 0842085D 0842130D 0845885D 0846565D 0847512D 9292011 0940124D 0940126D 0940127D 0941052D 0941067D 0942146D 0942277D 0942850D 0943496D 0944142D 0945209D 0945467D 0945715D 1040120D 1040385D 1040583D 1040805D 1041471D 1041627D 1041982D 1042493D 1043025D 1043102D 1043511D 1043778D 1044521D 1044523D 1046109D 1046189D 1046193D 1141605D 1141791D 1142149D 1142927D 1143476D 1143648D 1143972D 1144238D 1144345D 1144346D 1144395D 1144642D 1144656D 1144961D 1145073D 1145344D 1145810D 1145941D 1146537D 1146660D 1146661D 1240125D 1240950D 1241422D 1241512D 1242235D 1242642D 1242713D 1242929 1242929D 1243097 1243097D 1243552 1244644 1340202 1340554 1340554H 1341605 1341605H 1341606 1341606H 1341608 1341608H 1343303 1343303H 1343724 1343724H 1345516 1345516H 1346542 1346542H 1346543 1440947 1440947H 1440955 1440955H
  • 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, 10MM PEEK MONOPOLAR HANDLE, P/N 0250080618 || 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

Manufacturer

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