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Type of Product	Medical Device
TGA Recall Reference	RC-2018-RN-00268-1
Product Name/Description	StoneBreaker Pneumatic Lithotripter and associated accessories StoneBreaker Pneumatic Lithotripter, StoneBreaker Exhaust Cap, StoneBreaker Exhaust Line, StoneBreaker Probe Cap, StoneBreaker Sterilisation Cap, StoneBreaker CO2 Cartridge, StoneBreaker Single Use Probe Part Numbers: SBL-KIT1, SBA-EC, SBA-EL, SBA-PC, SBA-SC, SBC-10, SBP-010500, SBP-010605, SBP-016500, SBP-016605, SBP-020425 All Lot Numbers ARTG Numbers: 203852 and 203319
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	28/03/2018
Responsible Entity	William A Cook Australia Pty Ltd
Reason/Issue	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.
Recall Action	Recall
Recall Action Instructions	Cook Medical is advising all users to cease use and quarantine the affected products. All affected product is to be returned to Cook Medical. This action has been closed out on 13/08/2019
Contact Information	1800 777 222 - Cook Medical Customer Service