Events

Ligasure blunt tip laparoscopic sealer/divider 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Covidien 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 연번
    MDA/2011/026
  • 날짜
    2011-03-15
  • 사례 출판 날짜
    2014-12-17
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/medical-device-alert-ligasure-blunt-tip-laparoscopic-sealer-divider-potential-risk-of-serious-thermal-burns
  • 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
    During diathermy (electrosurgery) procedures the device may spontaneously energize when clamping, without the activation button being pushed.Although no injuries have been reported, this could cause an unintended energy delivery to tissue resulting in serious thermal burns.
  • 원인
    (covidien) device may spontaneously energize when clamping during diathermy (electrosurgery) procedures without pushing the activation button, which could lead to unintended energy delivery to tissue. (mda/2011/026).
  • 조치
    The manufacturer is conducting a recall of specific lots.Identify affected devices from the lot numbers indicated on the Field Safety Notice (see appendix). Quarantine any affected devices and arrange for their return to Covidien.The MHRA is issuing this alert as there has been a poor response from users to the recall.

Device

Ligasure blunt tip laparoscopic sealer/divider
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Ligasure blunt tip laparoscopic sealer/divider.Manufactured by Covidien.Catalogue number: LF1537.Specific lot numbers.
  • Manufacturer
    Covidien

Manufacturer

Covidien
  • 제조사 주소
    Covidien (UK) Commercial Ltd 154 Fareham Road Gosport Hampshire PO13 0AS Tel: 01329 224000 Fax: 01329 224418Email: PRMS.ComplaintsDepartment@covidien.com
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    MHRA