Component code = 4756 - aquabeam console, a reusable component of the aquabeam robotic system, controls the functionality of the high-velocity waterjet delivered by the aquabeam handpiece.Root cause of the reported event has not yet been established.Investigation by manufacturer is currently in-process.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
|
A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that during the aquablation procedural setup, the aquabeam handpiece pump cartridge was unable to latch into the aquabeam console.Upon further inspection, the latch was found to be loose as well.As a result, the procedure was aborted.There were no adverse health consequences to the patient due to this event.
|
The aquabeam console was returned for investigation.Functional testing was conducted by connecting the the returned console to a test system.An attempt was made to connect qa handpiece into the returned console, and it was unsuccessful as the console latch could not lock the handpiece in place.Reported failure mode was confirmed.The console was disassembled for further analysis.The high pressure pump assembly was removed from the console and opened up.Remnants of broken helical gear could be observed inside the high pressure pump assembly.The root cause is mechanical component failure as the helical gear broke,.However, root cause source is undeterminable.It is likely that the pump cartridge was in a suboptimal position while attempting to lock it in place and the force applied caused the helical gear to shatter into pieces.A review of the device history record (dhr) ab2000-b / serial number (b)(6) and aquabeam console / lot number 21c00935 was conducted, which confirmed which confirmed that there were no non-conformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.The review indicated that the device met all design and manufacturing specifications when released for distribution.Um0101-00, rev f aquabeam robotic system user manual, us was reviewed and states the following: 5.1 precautions: general.· assess the condition of all components prior to the aquablation procedure.If any component seems damaged or faulty, do not use the device.Replace the suspect device and/or contact procept.5.2 precautions: aquabeam robotic system setup.· ensure the aquabeam robotic system electrical connections are properly installed and secure.Failure to do so may result in user or patient injury.Table 4 aquabeam robotic system status indications.Confirm cartridge is fully seated into pump head and close latch (note: latch provides a tactile click upon closure).Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
|