Modulith SLX-F2 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Storz Medical 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
  • 날짜
    2016-03-01
  • 사례 출판 날짜
    2016-03-01
  • 사례 국가
  • 사례 출처
    DH
  • 사례 출처 URL
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: storz medical modulith slx-f2 the medicines and healthcare products regulatory agency (mhra) of united kingdom posted a medical device safety alert concerning modulith slx-f2 manufactured by storz medical. the affected serial numbers are 0r.079, 0r.269, 0r.110 and 0r.299. the system includes a table insert from carbon fibre as part of the optional urology kit. the manufacturer has observed that due to the addition of tolerances of the table insert and the table cutout, the table insert can slip out of place. during patient treatment the slipping of the insert plate can lead to a sudden downward movement of the patient. according to the manufacturer, this patient movement will be compensated by the patient foil after a few centimeters. nevertheless, if at this moment an endoscopic instrument is inserted into the patient, serious injury may occur. to prevent the risk of injuries, the manufacturer advises that user must make sure that the lithotripter is no longer operated in combination with the actual carbon fibre insert plate. for details, please refer to the mhra website:https://www.Gov.Uk/drug-device-alerts/field-safety-notices-22-february-to-26-february-2016 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 1 march 2016.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Storz Medical Modulith SLX-F2
  • Manufacturer

Manufacturer