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-2015-RN-00475-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-06-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00475-1
  • 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 australia is issuing revised manual cleaning and high level disinfection procedures for the tjf-q180v duodenoscope. users are not required to return any devices to olympus.Further to olympus’ safety alert notification issued in march 2015, the manufacturer has since issued new reprocessing procedures applicable to the tjf-q180v duodenoscope. key changes in the new reprocessing procedures are:-- inclusion of a new single use brush (maj-1888), for cleaning around the forceps elevator- increase the number of raising/lowering of the forceps elevator and flushing of the elevator recess during pre-cleaning and manual cleaning.Ancillary cleaning items (single use soft brushes and a new reprocessing manual) have been sent to the relevant endoscopy units pertaining to this recall for product correction.
  • 조치
    Users are asked to implement the new reprocessing procedures for the TJF-Q180V and to ensure that all personnel involved in the reprocessing are knowledgeable and thoroughly trained on the new procedures. This action has been closed-out on 13/10/2016.

Device

TJF-Q180V Duodenoscope

Manufacturer

Olympus Australia Pty Ltd