Events

CEM Nosecone for use with CUSA Excel/Excel+ Ultrasonic Aspirator 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-2013-RN-00046-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-01-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00046-1
  • 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 notified by the manufacturer that since 2009 they have received a small number of complaints for cusa tip breakage. the manufacturer's investigation of these complaints identified that when the tips are used under specific circumstances with the cem nosecone, there is the potential for erosion of the cusa tip. the erosion can potentially lead to tip breakage.Specifically, the potential for cusa tip erosion occurs only during cem operation and if the side of the tip, rather than the annulus of the tip, is in contact with the tissue.
  • 조치
    Integra Neurosciences Pty Ltd is revising the package insert to include an additional warning advising users to ensure that only the CEM Nosecone contacts the intended tissue at the annulus of the tip and not the side of the tip to avoid tip breakage.

Device

CEM Nosecone for use with CUSA Excel/Excel+ Ultrasonic Aspirator
  • 모델명 / 제조번호(시리얼번호)
    CEM Nosecone for use with CUSA Excel/Excel+ Ultrasonic AspiratorCatalogue Numbers: C6623, C6636All lot numbers affectedARTG Number: 197945
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd