Events

Cochlear Baha Soft Tissue Gauge (included in the Cochlear Baha Attract surgical tool kit) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Cochlear 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-00452-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-04-16
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00452-1
  • 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
    The cochlear baha soft tissue gauge, part #95070 may have a manufacturing imperfection in the smooth surface of the metal. while this imperfection is minimal, cochlear's risk analysis has indicated that it could potentially leave residual metal on the patient’s skin. to date there have been no adverse events reported to cochlear associated with the use of this instrument.
  • 조치
    Cochlear will remove and replace current Soft Tissue Gauge with an unaffected instrument as quickly as possible. This new instrument has passed additional inspection under microscope to ensure it is not affected by this issue. The instruments removed from the field will also be subjected to the additional inspection under microscope and, if unaffected, be returned for use as required. Any instruments failing additional inspection under microscope will be scrapped. There is no change to clinical management guidelines for patients who have had implant surgery using this instrument.

Device

Cochlear Baha Soft Tissue Gauge (included in the Cochlear Baha Attract surgical tool kit)
  • 모델명 / 제조번호(시리얼번호)
    Cochlear Baha Soft Tissue Gauge (included in the Cochlear Baha Attract surgical tool kit) Part Number: 95070ARTG Number: 205705
  • Manufacturer
    Cochlear Ltd

Manufacturer

Cochlear Ltd