Events

Neptune 2 Rover Ultra and Neptune Bronze Rover (Mobile unit used as surgical fluid/smoke waste management system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Stryker 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-2013-RN-00265-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-05-30
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00265-1
  • 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
    Further to the 'recall for product correction' undertaken in june 2012 (tga recall ref. # rc-2012-rn-00561-3) stryker in the usa received two reports of serious injury or death in procedures where neptune 2 was connected to a passive chest drainage tube or closed wound drainage device post-operatively. as a result of the additional reported adverse events, stryker is requiring additional actions to be implemented in order to continue to use the neptune device(s).
  • 조치
    Stryker will arrange for a warning label and placard to be added to each Neptune device. Stryker is asking hospitals to ensure that all users of the Neptune device, including surgeons, surgical residents and health profession students are adequately trained, and are aware of the risks associated with the device. Education training is also provided in the form of a web based presentation for all Neptune Users. Training can be accessed via www.strykerwastemanagement.com.au using Login: neptune Password: stryker. A DVD will be made available as a further alternative for continued and ongoing training.

Device

Neptune 2 Rover Ultra and Neptune Bronze Rover (Mobile unit used as surgical fluid/smoke waste ma...
  • 모델명 / 제조번호(시리얼번호)
    Neptune 2 Rover Ultra and Neptune Bronze Rover (Mobile unit used as surgical fluid/smoke waste management system)Neptune 2 Rover Ultra Catalogue Number: 0702-002-000All Serial NumbersNeptune Bronze RoverCatalogue Number: 0700-007-000All Serial NumbersARTG Number: 164275
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • 제조사 모회사 (2017)
    Stryker
  • Source
    DHTGA