Events

ReNew Reusable Tips (Scissors, Graspers and Dissectors) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 C R Kennedy & Co 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-01152-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-09-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01152-1
  • 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
    Microline surgical has received customer reports that the heat-shrink insulation tube of renew reusable scissor, grasper and dissector tips may split during autoclave sterilisation/re-sterilisation. if a split occurs, the heat-shrink could fall off during a surgical procedure and if cautery is needed, there is a potential for burn due to insulation failure.This issue is due to a malfunction related to the heat-shrink insulation tube that is located immediately proximal to the metal tip.
  • 조치
    1. Users are to complete and return the supplied response form to the sponsor, even if the affected goods are no longer in possession. 2. A CR Kennedy Representative will contact customers to: a. Provide directions to initiate an RMA (Returned Material Authorisation) for the return of the ReNew Reusable tips at your facility. b. Discuss the availability of ReNew Disposable Tips that are counterparts to the Reusable items (where applicable). c. Organise a credit for all product returns to customer accounts.

Device

ReNew Reusable Tips (Scissors, Graspers and Dissectors)
  • 모델명 / 제조번호(시리얼번호)
    ReNew Reusable Tips (Scissors, Graspers and Dissectors)All Product CodesARTG Number 192108
  • Manufacturer
    C R Kennedy & Co Pty Ltd

Manufacturer

C R Kennedy & Co Pty Ltd