Events

Device Recall DS Titanium Ligation Clip 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Aesculap Implant Systems LLC 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
    79530
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1290-2018
  • 사례 시작날짜
    2018-01-22
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162596
  • 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
    Clip, implantable - Product Code FZP
  • 원인
    Added a contraindication to ifu: do not use the ds clips for living donor nephrectomies. added other contraindications. a publication from 2017 recommended aesculap ds clips for kidney transplantation with living donors. the information from this publication was not approved or validated by the firm.
  • 조치
    A letter and copy of the updated IFU was sent to affected customers the week of January 15, 2018. Product does not need to be returned. IFU is revised and put on the Aesculap Website for usage. https://www.aesculapusa.com/products/instructions-for-use.

Device

Device Recall DS Titanium Ligation Clip
  • 모델명 / 제조번호(시리얼번호)
    DS Clips - Product Numbers PL450SU DS SINGLE FIRE LIG.CLIPS PL471SU DS SINGLE FIRE LIG.CLIP L W/LATCH PL453SU DS SINGLE FIRE LIG.CLIP SM PL475SU DS SINGLE FIRE LIG.CLIP XL W/LATCH PL459SU DS SINGLE FIRE LIG.CLIP M PL462SU DS SINGLE FIRE LIG.CLIP ML PL465SU DS SINGLE FIRE LIG.CLIP ML W/LATCH PL468SU DS SINGLE FIRE LIG.CLIP L (all clips going back 5 years)
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US and Canada distribution
  • 제품 설명
    DS Titanium Ligation Clip, used in laparoscopic surgery
  • Manufacturer
    Aesculap Implant Systems LLC

Manufacturer

Aesculap Implant Systems LLC
  • 제조사 주소
    Aesculap Implant Systems LLC, 3773 Corporate Pkwy, Center Valley PA 18034-8217
  • 제조사 모회사 (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA