Events

Beaver 4.0mm Banana Blade 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Smith & Nephew 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-2016-RN-00093-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-01-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00093-1
  • 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
    A number of customer complaints have been received indicating that during arthroscopic hip surgery the blades are experiencing brittle fracture.In the event the instrument breaks, the failure is visually obvious to the user and the broken blade can be retrieved. in a rare instance the device could break and fall into surgical site or joint space, making it difficult to retrieve. this can potentially cause a surgical delay. it has also been reported that in rare cases the broken blade remained in the patient.
  • 조치
    Smith & Nephew is advising users to immediately discontinue the use of the affected units prior to their quarantine and return.

Device

Beaver 4.0mm Banana Blade
  • 모델명 / 제조번호(시리얼번호)
    Beaver 4.0mm Banana BladeModel Number: 72203307Various Batch Numbers affectedARTG Number: 140406
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd