Events

Matrix Surgical Laparoscopic Spatula with Cable (Active endotherapy device) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Matrix Surgical 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-00020-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-01-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00020-1
  • 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
    This is a follow up to an earlier recall (tga reference: rc-2012-rn-00637-3) where the insulation of a diathermy spatula appeared to have melted during use and that the patient sustained secondary site damage to their fallopian tube. the manufacturer has determined that the safest maximum operating level for the diathermy spatulas is 30 watts.
  • 조치
    Matrix Surgical is advising users to quarantine affected stock for return to Matrix Surgical for replacement or credit note. Updated Instructions for Use (IFU) will be provided to all users along with the newly supplied devices. This action has been closed-out on 11/02/2016.

Device

Matrix Surgical Laparoscopic Spatula with Cable (Active endotherapy device)
  • 모델명 / 제조번호(시리얼번호)
    Matrix Surgical Laparoscopic Spatula with Cable (Active endotherapy device)Product Code: UFPS-133057Lot Numbers: 817101080, 8081106264Product Code: UFPS-133058Lot Numbers: 8191203108, 8191206116, 8191208096, 8191211137, 8191305131, 8191309178Product Code: UFPS-145058Lot Numbers: 8301012171, 4871304081, 830100357ARTG Number: 169175
  • Manufacturer
    Matrix Surgical Pty Ltd

Manufacturer

Matrix Surgical Pty Ltd