Events

Laser Guide, Endotherapy, single use - TXMF600BFS Fibres, when using pullback device 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Device Consulting 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-2017-RN-00707-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-05-30
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00707-1
  • 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
    Device consulting has received three reports of the fibre sliding inside the sheath when the pullback device was being used. to date, no injuries have been reported. it has been determined by the manufacturer that when a pullback device is in use, the fibre can slide inside the sheath because the tuohy borst adaptor does not grip the fibre firmly due to a faulty o-ring. should this occur during a procedure on a patient, surgical intervention would be required to remove the section of sheath that had separated.
  • 조치
    Device Consulting will be replacing all units from the affected batches at facilities which use pullback devices. In the interim, TXMF600BFS fibres can continue to be used until the replacement is received provided that users pullback manually by pulling the sheath.

Device

Laser Guide, Endotherapy, single use - TXMF600BFS Fibres, when using pullback device
  • 모델명 / 제조번호(시리얼번호)
    Laser Guide, Endotherapy, single use - TXMF600BFS Fibres, when using pullback deviceBatch Numbers: 1606018 and 1607019ARTG Number: 221756
  • Manufacturer
    Device Consulting Pty Ltd

Manufacturer

Device Consulting Pty Ltd