Events

ConMed MacroLyte Premie Dispersive Electrode(electrosurgical return electrode) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 ConMed Linvatec 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-2014-RN-00522-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-05-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00522-1
  • 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 has advised they have received complaints that the electrode gel may make contact with an internal staple causing no output, sparking and heat build-up between the staple and the electrode foil contact surface. whilst there have been no complaints and no reports of injury or death received by the product sponsor in australia, one patient in japan was reported to have received a skin tear.
  • 조치
    ConMed is requesting their customer to immediately discontinue the use of the device and arrange for its return. This action has been closed-out on 29/01/2016.

Device

ConMed MacroLyte Premie Dispersive Electrode(electrosurgical return electrode)

Manufacturer

ConMed Linvatec Australia Pty Ltd