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 (dhr) for ab2000-b rev c/serial number (b)(6) 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 device met all design and manufacturing specifications when released for distribution.A review for similar complaints under ab2000-b rev c/serial number (b)(6) confirmed no other similar events.A review of similar complaints across all other systems confirmed no other similar events.The aquabeam robotic system instructions for use, ifu0104-00 rev.B, states: 4.3 warnings: procedure.As with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: - bladder neck contracture.A root cause for the reported event could not be determined.The aquabeam robotic system's ifu lists bladder neck contracture as 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.No additional information was able to be obtained through the treating physician.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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