Events

Integra CUSA Clarity Footswitch packaged with CUSA Clarity Console C7000 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Integra Neurosciences 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-2017-RN-01276-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-10-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01276-1
  • 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
    Integra neurosciences has been advised that certain lots of footswitch supplied with the cusa clarity console may be faulty.A faulty footswitch may result in unintended ultrasonic fragmentation activation. there are two scenarios during which the failure mode may occur:1. ultrasonic fragmentation may be activated after set-up is complete and the user goes to the main screen (without the footswitch pressed); and/or2. ultrasonic fragmentation may remain activated during surgical use once the footswitch amplitude pedal is disengaged.There have been no adverse events or injury reported.
  • 조치
    Integra is advising users to quarantine the affected units from use. Affected units will be replaced with unaffected stock.

Device

Integra CUSA Clarity Footswitch packaged with CUSA Clarity Console C7000
  • 모델명 / 제조번호(시리얼번호)
    Integra CUSA Clarity Footswitch packaged with CUSA Clarity Console C7000Catalogue Number: C7002Lot Numbers: 1885744, 1923802, 1985221, 2057996, 2109587 and 2118507ARTG Number: 283158
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd