URETERO-RENO VIDEOSCOPE 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 OLYMPUS CANADA INC. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    138682
  • 사례 위험등급
    II
  • 사례 시작날짜
    2016-12-22
  • 사례 국가
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 데이터 추가 비고
  • 원인
    There was an investigation of customer complaints regarding the breakage of the endoscope's insertion tube bending section during surgical procedures. to date some of these complaints are associated with tissue trauma including one complaint of perforation and two complaints of insertion tubes which were stuck inside the patient and had to be surgically removed. olympus is providing a two-page instructions for safe use to remind customers of inspection instructions in the existing operation manual and also provide pictures and instructions to assist in performing the inspection.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: URF-V2R (Lot serial: ALL SERIAL NUMBERS); Model Catalog: URF-V2 (Lot serial: ALL SERIAL NUMBERS)
  • 제품 설명
    URETERO-RENO VIDEOSCOPE
  • Manufacturer

Manufacturer