Events

DGP-HP RFA High-Power single use grounding pad and Cool-tip RFA Electrode Kits, Cool-tip RF System Electrode kits cluster, Cool-tip RF System Accessories 에 대한 현장 안전성 서한

ALIMS (Agencija za lekove i medicinska sredstva)에 따르면, 해당 현장 안전성 서한 는 Serbia 에서 Covidien LP 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 출판 날짜
    2012-09-18
  • 사례 국가
    Serbia
  • 사례 출처
    ALIMSA
  • 사례 출처 URL
    https://www.alims.gov.rs/latin/2012/09/18/obavestenje-o-meri-povlacenja-sa-trzista-medicinskih-sredstava-koja-sadrze-jastucice-za-uzeml%D1%98enje/
  • 비고 / 경고
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • 데이터 추가 비고
  • 원인
    The manufacturer has decided to implement a safety corrective measure in the field, ie withdrawal of the medical device from use, due to the risk posed on the grounding pad, which leads to degradation of the foil and release unwanted heat that can cause burns in patients. covidien received four reports of serious injuries, that is, burns at the location of the electrode pad. cool-type rf system accessories also contains grounding pads so that there is also the risk of an adverse reaction - burns.

Device

DGP-HP RFA High-Power single use grounding pad and Cool-tip RFA Electrode Kits, Cool-tip RF Syst...
  • 모델명 / 제조번호(시리얼번호)
    168583 - 213736X, 171281 - 215747X, 168576 - 214355X, 170882 - 214971X, 168571 - 213013X, 169419 - 220740, 168854 - 213368X, 168574 - 214434X, 169684 - 214973, 171300 - 208194X, 168575 - 215632, 168853 - 213703X, 170383 - 213699X, 169683 - 213042X, 169683 - 213042X, 170384 - 215746X, 184240 - 205456, 177906 - 214357X, 191404 - 205455, 162732 - 214867X
  • Manufacturer
    Covidien LP

Manufacturer

Covidien LP
  • 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
    ALIMSA