Events

Thermablate Endometrial Ablation System (EAS) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Gytech 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-2015-RN-00360-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-04-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00360-1
  • 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 instructions for use (ifu) of the thermablate endometrial ablation system (eas) is updated due to four case reports of uterine perforation. there is an increased risk of patient injury (including damage to non-targeted tissue) if both thermablate eas procedure and hysteroscopic tubal occlusion/sterilisation are performed on the same day.
  • 조치
    Additional warning is being added to the IFU as follows : "Do not perform same day Thermablate EAS procedure and hysteroscopic tubal occlusion/sterilization. Thermablate EAS procedure can be safely and effectively performed with nickel titanium inserts in place, however the procedure should only be performed after the 3 month tubal occlusion confirmation test." Gytech Pty Ltd is informing the customers of the additional warning as updated in the Instructions For Use (IFU). The IFU document (Ref. No: LS2101, Rev C) currently supplied with the Disposable Cartridge already includes these changes. This action has been closed-out on 5/08/2016.

Device

Thermablate Endometrial Ablation System (EAS)
  • 모델명 / 제조번호(시리얼번호)
    Thermablate Endometrial Ablation System (EAS)Thermablate Treatment Control Unit Kit Product Code: I-22001Thermablate Disposable Cartridge Product Code: 1-21004All Lot NumbersARTG Number: 186661
  • Manufacturer
    Gytech Pty Ltd

Manufacturer

Gytech Pty Ltd