Events

TJF-Q180V Duodenoscope 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Olympus Australia Pty Ltd 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
    RC-2016-RN-00098-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-01-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00098-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    Olympus has received reports of patient infections associated with the elevator sealing mechanism of the tjf-q180v duodenoscope. olympus is updating the existing tjf-q180v operation manual, the tjf-q180v reprocessing manual and will perform a correction to the forceps elevator mechanism. this is further to the urgent recall for product correction notification issued in june 2015 (tga ref: rc-2015-rn-00475-1).
  • 조치
    Affected units can continued to be used, provided the leakage test as outlined in the revised Reprocessing Manual is performed before every use. Olympus is providing instructions for users to access the updated Operation and Reprocessing Manual. Olympus is undertaking a correction of all affected TFJ-Q180V elevator mechanisms and will provide users with loan units whilst the units are being repaired. This action has been closed-out on 27/02/2017.

Device

TJF-Q180V Duodenoscope

Manufacturer

Olympus Australia Pty Ltd