EnSeal G2 SuperJaw (Used for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Johnson & Johnson Medical 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-2013-RN-00328-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-04-17
  • 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 identified an increase in adverse events with enseal g2 superjaw for suspected thermal injuries related to the use of the device.
  • 조치
    Johnson & Johnson Medical (JJM) is updating the instructions for use to prevent the issues from occurring in the field. JJM has advised the TGA that they are further reviewing the post-market surveillance data and will advise the TGA regarding the outcomes of this review.

Device

  • 모델명 / 제조번호(시리얼번호)
    EnSeal G2 SuperJaw (Used for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures)Product Code: NSEALX22LARTG Number: 165469
  • Manufacturer

Manufacturer