Events

PlasmaSORD 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Olympus Australia 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-00112-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-02-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00112-1
  • 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
    Based on a concern raised in the us relating to the potential risk of transcoelomic spread of undiagnosed cancerous tissue with the use of morcellators in the treatment of uterine fibroids, the manufacturer has issued an updated ifu which has been included in this communication.
  • 조치
    Olympus is notifying hospitals of the expanded contraindications, warnings and risk associated with the use of power morcellators. The TGA has published information on the risks associated with power morcellators on the TGA website at: - https://www.tga.gov.au/alert/laparoscopic-power-morcellators-29-april-2014 - https://www.tga.gov.au/alert/laparoscopic-power-morcellators-update-4-august-2014. This action has been closed-out on 18/07/2016.

Device

PlasmaSORD
  • 모델명 / 제조번호(시리얼번호)
    PlasmaSORDProduct Code: 962000PKARTG Number: 141561
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd