Events

StoneBreaker Pneumatic Lithotripter and associated accessories StoneBreaker Pneumatic Lithotripter, StoneBreaker Exhaust Cap, StoneBreaker Exhaust Line, StoneBreaker Probe Cap, StoneBreaker Sterilization Cap, StoneBreaker CO2 Cartridge, StoneBreaker Single Use Probe 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-2018-RN-00268-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2018-03-28
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00268-1
  • 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
    Cook medical is initiating a recall of the stonebreaker pneumatic lithotripter and associated accessories. the product is intended for reprocessing at the user facility. cook medical has identified a number of issues relating to the instructions for use (ifu) which may affect the sterility of the device.- the interior of the product may not be sterilised to the appropriate sterility assurance level when following the reprocessing instructions provided in the instructions for use. - the co2 cartridge pouch may be susceptible to tearing.- the exhaust line (purchased separately) does not include re-processing instructions.- the o-ring in the handle may swell during use, leading to leakage and loss of power.Potential adverse events that may occur include urinary tract infection (uti), pyelonephritis, and urosepsis and device leaking and loss of power.
  • 조치
    Cook Medical is advising all users to cease use and quarantine the affected products. All affected product is to be returned to Cook Medical.

Device

StoneBreaker Pneumatic Lithotripter and associated accessories StoneBreaker Pneumatic Lithotripte...
  • 모델명 / 제조번호(시리얼번호)
    StoneBreaker Pneumatic Lithotripter and associated accessoriesStoneBreaker Pneumatic Lithotripter, StoneBreaker Exhaust Cap, StoneBreaker Exhaust Line, StoneBreaker Probe Cap, StoneBreaker Sterilization Cap, StoneBreaker CO2 Cartridge, StoneBreaker Single Use ProbePart Numbers: SBL-KIT1, SBA-EC, SBA-EL, SBA-PC, SBA-SC, SBC-10, SBP-010500, SBP-010605, SBP-016500, SBP-016605, SBP-020425All Lot NumbersARTG Numbers: 203852 and 203319
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd