Device Recall PKG, PKG, HOOK SCISSORS 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-0639-2015
  • 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)
    41490 44630 140583 142467 142469 143688 144270 246031 440310 443401 443405 443406 443407 542490 542498 542499 641965 641966 641968 645668 741519 741520 741521 741523 744992 744994 744995 747000 747001 747002 841991 842244 842246 842248 842259 842263 842267 842271 842876 941705 942762 942846 943012 943044 943107 943247 943417 943747 944089 944704 944838 944885 945128 945554 945555 945557 945558 945559 945562 945564 945565 945568 945569 1042239 1042474 1044885 1046102 1046734 1046735 1140692 1141608 1142179 1143096 1143097 1144503 1145104 1145105 1146377 1146378 1147161 1147162 1241404 1242145 1242261 1243810 1244133 1244439 1245093 1245235 1245831 1246051 1246185 1340227 1340932 1340933 1341825 1342200 1342201 1342202 1343515 1343516 1345798 1440785 1441076 1442552
  • 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, PKG, HOOK SCISSORS, P/N 0250080260. || 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