A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that during the aquablation procedure, the aquabeam console pump cartridge was not able to engage with the aquabeam handpiece.Two handpieces were replaced in attempts to troubleshoot the issue unsuccessfully, rendering the console inoperable.As a result of this event, the aquablation procedure was aborted.There were no adverse health consequences to the patient due to this event.
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H.10 additional manufacturer narrative: the aquabeam console was returned for investigation.Functional testing was able to confirm the reported event as the related aquabeam handpieces and a qa test handpiece were unable to be inserted into the console.Attempts to insert the related handpieces and a qa handpiece into the returned console were unsuccessful as the pump cartridge slot was stuck in the lock position.Rotating the pump cartridge latch could not unlock the slot to allow a handpiece to be inserted.The console was then deconstructed and it was observed that the helical gear was broken.A review of the device history record (dhr) for aquabeam robotic system/serial number (b)(6) and the aquabeam console / lot number 21c00919 was performed, which confirmed that there were no nonconformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.The review indicated that the system and its associated component met all design and manufacturing specifications when released for distribution.Aquabeam robotic system user manual, um0101-00 rev.F, was reviewed and states the following: 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).The root cause is undeterminable as it is unknown exactly what caused the helical gear to break.However, 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.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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