Events

Fujifilm ED-530XT Duodenoscope 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Fujifilm 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-00034-2
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-04-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00034-2
  • 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
    The operation manuals have been revised to reflect newly validated manual cleaning and high-level disinfection procedures. this action is being taken as a result of reports of multi-drug resistant bacteria on endoscopesused for endoscopic retrograde cholangiopancreatogram (ercp) procedures. revisions have been made to the ed-530xt operation manuals, “preparation and operation” and “cleaning, disinfection and storage.” these revisions modify the cleaning and disinfection processes and require the use of a new disposable distal end cleaning brush to be used for the cleaning of the duodenoscope’s distal tip, forceps elevator and elevator recess, in addition to use of the existing fujifilm valve cylinder cleaning brush.
  • 조치
    FujiFilm is providing users with updated instructions manuals and samples of the new disposable distal end cleaning brush. All previous versions of the IFU should be discarded. This action has been closed-out on 01/03/2018.

Device

Fujifilm ED-530XT Duodenoscope
  • 모델명 / 제조번호(시리얼번호)
    Fujifilm ED-530XT Duodenoscope Serial Numbers: MD102A129, MD102A130ARTG Number: 139172
  • Manufacturer
    Fujifilm Australia Pty Ltd

Manufacturer

Fujifilm Australia Pty Ltd