Events

MAJ-1606 instrument adaptor (designed for use with the Olympus MAJ-1607 instrument channel water tube) 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-00991-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-10-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00991-1
  • 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
    Small puncture marks that are not easily visible by eye have been found on the packaging of the maj-1606. this damage was caused by variations in the packaging process.A sample of devices with these small puncture marks was sent by the manufacturer for bio-burden testing. this testing concluded that no bacterial contamination was detected from any of the adaptors sampled.Both the manufacturer and olympus have not received any complaints of injury associated with compromised sterile packaging, however, as a precaution olympus is recalling the two affected lot numbers.
  • 조치
    Customers are asked to immediately cease use of any affected product they have and to quarantine affected units until they can be returned to Olympus as per the instructions in the Customer Letter. A credit or replacement will then be issued free of charge for any returned product. This action has been closed-out on 05/09/2016.

Device

MAJ-1606 instrument adaptor (designed for use with the Olympus MAJ-1607 instrument channel water ...
  • 모델명 / 제조번호(시리얼번호)
    MAJ-1606 instrument adaptor (designed for use with the Olympus MAJ-1607 instrument channel water tube)Item Codes: K10016091 – MAJ-1606Lot Numbers: 20115441 and 20116536 ARTG Number: 222646
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd