A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that post-procedure the patient was taken back to the operating room due to bleeding possibly due to remnant prostatic tissue, which was addressed by performing greenlight laser treatment (per manufacturer's instructions for use, bleeding is a potential perioperative risk of the aquablation procedure).No adverse health consequences were reported with the patient due to this event.No malfunction of the aquabeam robotic system was reported.
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H.10 additional narrative/data: a review of the aquabeam robotic system's log file was reviewed, which confirmed no malfunctions during the aquablation procedure.The review indicated that the system functioned as designed.A review of the device history record (dhr) for serial number (b)(6) was conducted, which confirmed that there was a nonconformance generated during the manufacturing process of this system.The review indicated that the nonconformance is unrelated to the reported event.The system met all required specifications upon release for distribution.A review for similar complaints was performed on serial number (b)(6), which confirmed that there were no other similar events reported on this system.There are five (5) similar events that have been reported across all systems.The aquabeam robotic system's instructions for use (ifu), ifu0101-00, rev.D, was reviewed and states the following: 4.3.Warnings: procedure as with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: bleeding.A root cause for the reported event could not be determined.Bleeding is a potential risk of the aquablation procedure.Based on the review of the log file, dhr and ifu, the event is considered not to be device related.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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