Events

CUSA CEM™ nosecones for use with the CUSA® Excel/Excel+ ultrasonic aspirator 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Integra Lifesciences 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/2014/006
  • 사례 연번
    CON383409
  • 날짜
    2014-02-26
  • 사례 출판 날짜
    2014-02-26
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON383409?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
    Risk of burns to patient or user. the manufacturer has identified that the blue coag button on the cusa® excel cem™ nosecone could stick in the ‘activated’ position. this failure can occur whist the device is being used with the cusa® excel/excel+ ultrasonic aspirator. integra lifesciences is in the process of modifying the design to mitigate the risk of failure. the new design will not be available before the end of september 2014.
  • 조치
    Identify affected devices. Ensure members of staff are aware of the advice and guidance detailed in the manufacturer’s Field Safety Notice (FSN). Have spare nosecones readily available for use. Complete and return the manufacturer’s acknowledgement form. Use alternative devices where possible. Report any adverse incidents to Integra Lifesciences and the MHRA.

Device

CUSA CEM™ nosecones for use with the CUSA® Excel/Excel+ ultrasonic aspirator
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Electrosurgical devices. CUSA CEM™ nosecones for use with the CUSA® Excel/Excel+ ultrasonic aspirator. Product codes: C6623 and C6636.
  • Manufacturer
    Integra Lifesciences

Manufacturer

Integra Lifesciences