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 for serial number (b)(6) was conducted, 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 has been one (1) other similar event that has 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: urinary retention.A root cause for the reported event could not be determined.Urinary retention 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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