Events

motor for orthopedic surgery 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Stryker Instruments || Stryker Ireland-Instruments 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
    R1502-70
  • 사례 연번
    2008DM-0002802
  • 날짜
    2015-02-17
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=185
  • 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 reports that the laser welder could have failed in the continuous line union for the housings referenced, this fault in the welding could lead to the separation of the two housings sections causing the loss of mechanical connection between the handpiece and the battery, leading to generate possible adverse events on the patient and the prolongation of surgical time.

Device

motor for orthopedic surgery
  • 모델명 / 제조번호(시리얼번호)
    SYSTEM 6, model 6126-120-000, lots 13205, 13209, 13210 and 13212.
  • 제품 설명
    These equipments are destined to generate the controlled movement of its accessories and associated instruments in order to facilitate orthopedic procedures by means of power, speed in circular, rotating and oscillating movements controlled among others for efficient cuts and perforations in bone as well as for the placement and extraction of the materialatornillable of the osteosynthesis material.
  • Manufacturer
    Stryker Instruments || Stryker Ireland-Instruments

Manufacturer

Stryker Instruments || Stryker Ireland-Instruments
  • 제조사 모회사 (2017)
    Stryker
  • Source
    NIDFSINVIMA