Events

Recall of 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

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by William A Cook Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2018-RN-00268-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2018-03-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00268-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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...
  • Model / Serial
    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
  • Product Classification
    Gastroenterology-Urology Devices
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd