Events

Stapler Duet TRS™ universal straight and articulating single use loading units (SULU) 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/2012/005
  • 날짜
    2012-02-16
  • 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-stapler-duet-trs-universal-straight-and-articulating-single-use-loading-units-sulu-do-not-use-for-adult-or-paediatric-thoracic-surgery-procedures
  • 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
    Covidien has issued advice (369Kb) following reports of serious injuries that have occurred following the use of these devices in the thoracic cavity.These stapler loading units have the potential to injure adjacent anatomical structures within the thorax, which may result in life threatening post-operative complications.
  • 원인
    (covidien) reports of serious injuries after use of stapler duet trs™ loading units in the thoracic cavity.(mda/2012/005).
  • 조치
    Do not use these Duet TRSTM Loading Units for any adult or paediatric thoracic surgery procedures. Return any products purchased solely for thoracic use to the manufacturer, following the instructions in the manufacturer’s advice (369Kb).

Device

Stapler Duet TRS™ universal straight and articulating single use loading units (SULU)
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    StaplerDuet TRS™ universal straight and articulating single use loading units (SULU)Manufactured by CovidienProduct codes and descriptions of affected devices:Product code   Description DUET4535   Duet TRS™ 45 3.5mm straight SULU DUET4535A   Duet TRS™ 45 3.5mm articulating SULU DUET4548   Duet TRS™ 45 4.8mm straight SULU DUET4548A   Duet TRS™ 45 4.8mm articulating SULU DUET6035   Duet TRS™ 60 3.5mm straight SULU DUET6035A   Duet TRS™ 60 3.5mm articulating SULU DUET6048   Duet TRS™ 60 4.8mm straight SULU DUET6048A   Duet TRS™ 60 4.8mm articulating SULU
  • Manufacturer
    Covidien

Manufacturer

Covidien
  • 제조사 주소
    Amanda Woolven Covidien Commercial (UK) Ltd 4500 Parkway Whiteley Hampshire PO15 7NY Tel: 01329 224 435 Fax: 01329 224 418Email: Amanda.woolven@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