Events

Thermablate Endometrial Ablation System (EAS)Thermablate Treatment Control Unit Kit 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-2014-RN-00573-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-06-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00573-1
  • 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 action is undertaken to inform users of an update to the instructions for use (ifu) for the thermablate endometrial ablation system (eas). the ifu updates are in the following sections:1) directions for use / treatment - includes an additional precautionary step in the sequence of procedures just prior to inserting the thermablate catheter into the uterus to initiate treatment. the sequence now includes a requirement for a second sounding of the uterus just after dilation and before performing hysteroscopic examination of the uterus to confirm that perforation of the uterus or the creation of a false passage has not occurred during the dilation and soundings.2) contraindications – the current contraindication i.E., “a patient with lower segment c section scar that has a linear scar thickness of less than 1cm” is being amended to “a patient that has had three or more, lower segment c sections and where the linear scar thickness in those patients is less than 8mm”.
  • 조치
    Customers are provided with the updated IFU along with the customer letter. This action has been closed-out on 11/02/2016.

Device

Thermablate Endometrial Ablation System (EAS)Thermablate Treatment Control Unit Kit
  • 모델명 / 제조번호(시리얼번호)
    Thermablate Endometrial Ablation System (EAS)Thermablate Treatment Control Unit KitProduct Code : I-22101 Thermablate Disposable Cartridge Product Code : I-21004ARTG number: 186661
  • Manufacturer
    Gytech Pty Ltd

Manufacturer

Gytech Pty Ltd