H.10 additional manufacturer narrative: the aquabeam robotic system was not returned for investigation of this event and is currently in use at the user facility.The investigation consisted of a review of the information reported to procept, plus a review of the treatment log files, device history record (dhr), and labeling.The aquabeam robotic system's treatment log file was reviewed, which confirmed no malfunctions during the aquablation procedure.The review of the treatment log file indicated that the system functioned as designed.A review of the device history record (dhr) ab2000-b rev.G/serial number (b)(6) was conducted, 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 system met all design and manufacturing specifications when released for distribution.The aquabeam robotic system instructions for use (ifu), ifu0101-00, rev.E, was reviewed and states the following: 4.3.Warnings: procedure as with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: - incontinence or overactive bladder.A root cause for the reported event could not be determined.The patient was put on overactive bladder medication.The aquabeam robotic system instructions for use list incontinence or overactive bladder as a potential risk of the aquablation procedure.Based on the review of the treatment log files, dhr and ifu this 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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