Events

Sealing Caps (A0282 and A0313) used with compatible endoscopy instruments 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-2017-RN-00757-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-06-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00757-1
  • 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
    The manufacturer, olympus winter & ibe have identified specific item codes of sealing caps are missing information on the packaging that identifies the product as single-use and the sterility status of the sealing caps. these items are supplied unsterile and intended for single-use only following sterilisation. since there is no indication for single-use on the label it may be interpreted that the sealing cap can be reused. to date, olympus has not received any reports regarding adverse events or patient injury relating to this issue.
  • 조치
    Olympus is advising users to inspect their inventory for the affected Sealing caps and discard. Olympus will provide corrected replacement stock.

Device

Sealing Caps (A0282 and A0313) used with compatible endoscopy instruments
  • 모델명 / 제조번호(시리얼번호)
    Sealing Caps (A0282 and A0313) used with compatible endoscopy instrumentsAll A0282 and A0313 batches affected, supplied with instruments and separately.Item numbers of A0282 compatible instruments: A22091A, A42091A, A4743, A4764, A4773Item numbers of A0282 compatible instruments: A4772, A4776, A37005AARTG Number: 188523
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd