Events

Brachytherapy Systems 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Nucletron Operation B.V. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    A1708-389
  • 사례 연번
    2013EBC-0010303
  • 날짜
    2017-08-31
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=74
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • 데이터 추가 비고
  • 원인
    The manufacturer states that the routes of the measured sources of the referenced applicators, with a step size of the source of 2.5mm for the microselectron deferred charging device, constitutes the source of the alert, if this model of applicator is used to create an unplan, although the size of the step of the default source of the deferred loading device is 5.0mm, the size of the ovoid passage in the form of a ring or semicircular will be incorrect, 2.5 m will be indicated, although the deferred loading device will administer a dose at 5.0 mm. the error is detected during the approval of the plan, which may lead to the occurrence of potentially serious adverse events on the patient.

Device

Brachytherapy Systems
  • 모델명 / 제조번호(시리얼번호)
    Oncentra Brachy Planning System Version 4.5
  • 제품 설명
    Indicated for an operator to apply, by remote control, a radioactive source in the body through an interstitial, intracavitary, intraluminal, bronchial, endovascular, intraoperative applicator, radiation therapy for the treatment of cancer. Transplant applicators and tubes, an integral part of the brachytherapy system, are used to apply the radiation directly to the patient at the specific sites selected by the physician and are the only part of the system that has contact with the patient.
  • Manufacturer
    Nucletron Operation B.V.

Manufacturer

Nucletron Operation B.V.
  • 제조사 모회사 (2017)
    Elekta AB
  • Source
    NIDFSINVIMA