Events

E-Z Clean, L-Wire Laparoscopic Electrode Split Stem, 45cm (Single use electrosurgical electrode) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Big Green Surgical Company 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-00854-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-08-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00854-1
  • 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 distal portion of the electrode insulation of a small number of units may have been damaged during manufacture. in the event that a unit with damaged insulation is used on a patient contrary to recommended instructions for use supplied with the product, thermal damage could occur to the patient’s peripheral tissue. such damage would be outside the surgeon’s primary field of view during a laparoscopic procedure and therefore not easily identified at the time of occurrence. .
  • 조치
    Big Green Surgical is requesting users to quarantine all affected units. Affected stock will be replaced by Big Green Surgical or a credit note issued.

Device

E-Z Clean, L-Wire Laparoscopic Electrode Split Stem, 45cm (Single use electrosurgical electrode)

Manufacturer

Big Green Surgical Company Pty Ltd