A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procep) became aware that during the aquablation procedure, the aquabeam handpiece was unable to prime despite multiple troubleshooting steps, including replacing the handpiece with a new handpiece unit, without success.A third handpiece resolved the issue, and the procedure was continued through successful completion.The reported event caused a surgical procedural delay of over 20 minutes.There were no adverse health consequences to the patient due to the procedural delay.
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H.3 device evaluation by manufacturer: the aquabeam handpiece was returned for investigation.Visual inspection of the returned handpiece did not reveal any anomalies.Priming the handpiece at 50%/100% pump power was successful and no issues were observed.Additionally, a full simulated aquablation session was performed without issue.Priming was complete within a minute and reported failure mode could not be confirmed.The aquabeam robotic system instructions for use, ifu0101-00 rev.F, states the following: 8.14 sterile: ensure the aquabeam scope is fully advanced prior to priming.Press the "prime" button on the foot pedal or console and circle priming indicators (100% and 50%) will appear on the cpu.Press the [+] button on either the console or the motorpack to prime the aquabeam handpiece at 100% power level.Continue to press the [+] button until the 100% yellow indicator turns green.Release the [+] button while pressing the prime button until the 50% yellow indicator turns green.A review of the device history record (dhr) for aquabeam robotic system/serial number (b)(6) and the aquabeam handpiece / lot number 22c01168 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.The root cause of the reported event could not be established during the in-house investigation.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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