The aquabeam robotic system's log file was reviewed, which confirmed no malfunctions during the aquablation procedure.The review of the log file indicated that the system functioned as designed.A review of the device history record (dhr) serial number (b)(4) was 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)(4), which confirmed no other similar events have been reported on this system.A review of similar events on all other systems confirmed 4 other similar events.The aquabeam robotic system's instructions for use (ifu), ifu0101-00, rev.C, was reviewed and bleeding is listed as a potential perioperative risk of the aquablation procedure.As the product was not returned, 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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