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, which was addressed by clot evacuation and cauterization (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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H3.Device evaluation by manufacturer: the aquabeam robotic system was not returned for investigation as it is currently in use at the user facility.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 was performed for the aquabeam robotic system, serial number (b)(6), which confirmed that there were no nonconformances generated during the manufacturing process of the system.The review indicated that the system met required specifications prior to 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 ten (10) other similar events that have been reported across all other systems.The aquabeam robotic system 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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