H.10 additional narrative/data: the aquabeam robotic system's log file was reviewed and no malfunctions were observed.The review indicated that the system functioned as designed.A review of the device history record (dhr) for serial number (b)(6) as conducted, which confirmed that there were no nonconformances generated during the manufacturing process of this system.The review indicated that the system met all required specifications upon release for distribution.A review for similar complaints was performed on serial number (b)(6), which confirmed no other similar events reported on this device.There are no other similar events reported across all other systems.There are nine (9) other similar events across all other 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: o bleeding.A root cause for the reported event could not be determined.The aquabeam robotic system's ifu lists bleeding as a potential perioperative 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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