Diego Elite Tubeset, Standard and Declog(sterile devices intended to provide irrigation and suction when used with the Diego Elite system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Olympus Australia Pty Ltd 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
    RC-2017-RN-00142-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-01-31
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    A problem has identified a problem with the diego elite tubesets in which the internal shaft may become disengaged and cause the blade to stop spinning. if the drive shaft was to disengage during a procedure, the result may be a delay while the surgeon selects a replacement device. at this stage, no reports of injuries relating to the drive shaft disengagement have been received.
  • 조치
    Olympus is advising users to cease use of any affected products and quarantine affected stock prior to their return. They are further advised to contact Customer Service to arrange for issue of credit or replacement stock.

Device

  • 모델명 / 제조번호(시리얼번호)
    Diego Elite Tubeset, Standard and Declog(sterile devices intended to provide irrigation and suction when used with the Diego Elite system)Item Codes: TS100S and TS101DCMultiple Lot Numbers ARTG Number: 143268
  • Manufacturer

Manufacturer