Events

Devon™ Light Glove 에 대한 현장 안전성 서한

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는 Slovenia 에서 Medtronic 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
    Field Safety Notice
  • 사례 국가
    Slovenia
  • 사례 출처
    AMPMDRS
  • 비고 / 경고
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • 데이터 추가 비고
  • 원인
    The purpose of this letter is to advise you that medtronic is recalling its covidien devon™ light gloves distributed as single sterile items and in specific procedure kits. all lot numbers within expiry beginning with 630xxxxxxx and lower are affected. customers have reported that, on rare occasion, the devon™ light glove may split upon application to the devon™ light handle adapter. some of the reported splits resulted from difficult application of the light glove to the handle adapter. more recently, clinicians have reported finding splits in the light glove following surgery completion, where no difficulty in application of the light glove was encountered or finding splits directly out of the package. a split in the light glove causes a breach in the sterile field and can increase the potential for infection. medtronic has received notice of two patient adverse events (infection) in which light glove splits were found at the conclusion of surgery. medtronic requests that you quarantine and return any unused products of the item codes listed on attachment a. unused products should be returned as described in the required actions section below. if you have distributed the devon™ light glove products listed on attachment a, please promptly forward the information from this letter to those recipients. all unused products must be returned. .

Device

Devon™ Light Glove
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 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
    AMPMDRS