Events

Cook Bush SL and Bush DL Ureteral Illuminating Catheters(used for trans-illumination of the ureters during laparoscopic or open surgical procedures) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 William A Cook 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-00365-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-03-10
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00365-1
  • 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
    There has been an increase in reports that the proximal black component that connects to the distal transparent component of the catheter may overheat and melt. there have been no reports of overheating along the transparent component of the catheter, which is the part of the device that comes into contact with the patient’s urethra, bladder and ureter. potential adverse events that may occur if these devices overheat and come into direct contact with skin include burns to the skin.
  • 조치
    Customers are advised to quarantine and immediately return any affected product that remains unused to Cook Medical.

Device

Cook Bush SL and Bush DL Ureteral Illuminating Catheters(used for trans-illumination of the urete...
  • 모델명 / 제조번호(시리얼번호)
    Cook Bush SL and Bush DL Ureteral Illuminating Catheters(used for trans-illumination of the ureters during laparoscopic or open surgical procedures)Cook Bush SL Ureteral Illuminating Catheter Set Catalogue Numbers: 084100, 084120 , J-BICS-058020Part Numbers: G16745, G16746, G16737All LotsCook Bush DL Ureteral Illuminating Catheter Set Catalogue Numbers: 084520, 084510, J-BICS-078000Part Numbers: G16747, G16143, G16262All LotsARTG Number: 215910
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd