Events

Selector Tubing Kit for use with CUSA Selector Ultrasonic Aspirators 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-2014-RN-01079-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-10-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01079-1
  • 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 identified through an investigation of complaints that some specific lots of selector® tubing kits may potentially leak irrigation fluid during use if not placed on the selector handpiece in a specific manner. if the lumens of the 2 tubes are not separated before placing them on the handpiece barbs, this could result in an irrigation fluid leak. if the leakage is significant, the handpiece tip could overheat and possibly burn tissue being treated.
  • 조치
    Integra is providing additional instructions to prevent the occurrence of leakage. This action has been closed-out on 03/06/2016.

Device

Selector Tubing Kit for use with CUSA Selector Ultrasonic Aspirators
  • 모델명 / 제조번호(시리얼번호)
    Selector Tubing Kit for use with CUSA Selector Ultrasonic Aspirators Catalogue number: 1517079Multiple lot numbersARTG number: 146847
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd