Events

Stryker Neurovascular - III - 46352 - Neurovascular embolisation implant 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Stryker Neurovascular 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
    19898
  • 사례 시작날짜
    2016-03-18
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Stryker New Zealand Ltd, 515 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • 원인
    It was identified that the neuroform atlas pouch and carton label references the incorrect measurement in millimeters for the minimum catheter diameter. the minimum catheter diameter is correctly listed as 0.0165 inches on both product labels, but incorrectly converted to millimetres as 0.69mm. the correct conversion value is 0.42. the labelling discrepancy could lead to a physician selecting a catheter which is too large. the hazard associated with this is that the stent would prematurely deploy during transfer into the catheter. the result to the patient being extended procedure/ additional treatment required and increased time under anaesthesia. no adverse health consequences are anticipated. there is no risk to patients associated with previous use of affected devices.
  • 조치
    Manufacturer to issue advice regarding use

Device

Stryker Neurovascular - III - 46352 - Neurovascular embolisation implant

Manufacturer

Stryker Neurovascular
  • 제조사 모회사 (2017)
    Stryker
  • Source
    NZMMDSA