Events

Standard Offset Cup Impactor 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Greatbatch Medical 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert / Field Safety Notice
  • 사례 ID
    MDA/2014/031
  • 사례 연번
    CON437749
  • 날짜
    2014-07-24
  • 사례 출판 날짜
    2014-07-24
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON437749?tabName=allTabs
  • 비고 / 경고
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • 데이터 추가 비고
  • 원인
    Potential for infection from inadequately sterilized devices. the manufacturer has validated new sterilization parameters for these devices to address this issue. these parameters are provided in the manufacturer’s field safety notice (fsn) issued in march 2014. greatbatch originally sent a notification in january 2014, with one acceptable sterilization parameter, (validated to a sterility assurance level (sal) of at least 10-6). greatbatch has now validated an additional sterilization parameter for use with their device. both acceptable parameters are provided in the updated fsn dated march 2014. the mhra is issuing this medical device alert to ensure that all users are aware of the manufacturer’s updated fsn.
  • 조치
    Identify affected devices. Follow the updated sterilization instructions described in the FSN. All staff involved in sterilization of these devices. All orthopaedic staff that use these devices.

Device

Standard Offset Cup Impactor
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Greatbatch Medical: Standard Offset Cup Impactor
  • Manufacturer
    Greatbatch Medical

Manufacturer

Greatbatch Medical