CONMED Concept Heatwave Electrode, 130mm x 2.3mm diameter (5 per box) (electrosurgical electrode used for ablation of soft tissue and coagulation of vessels) 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-2016-RN-01129-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2016-08-26
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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 received complaints of damage to the electrode shaft insulation, which could increase the risk of a patient burn.To date, conmed has not received any reports where this has led to illness or injury.
  • 조치
    ConMed Linvatec is advising users to immediately discontinue use of the affected product and to return it to ConMed Linvatec for credit or replacement. This action has been closed-out on 10/05/2017.

Device

  • 모델명 / 제조번호(시리얼번호)
    CONMED Concept Heatwave Electrode, 130mm x 2.3mm diameter (5 per box) (electrosurgical electrode used for ablation of soft tissue and coagulation of vessels)Reference/Catalogue Number: CS-023Affected Lots: 267221 to 695063ARTG Number: 94017
  • 의료기기 분류등급
  • Manufacturer

Manufacturer