A review of the system's log file was conducted, which confirmed that there were no malfunctions observed during the procedure.No system malfunctions were observed.A review of the device history record (dhr) for the aquabeam system, lot number 18c00144, was conducted, which confirmed that there were no nonconformances generated during the manufacturing process of this system, which could relate to the reported event.The review indicated that the system met all required specifications when released for distribution.A review for similar events was conducted on the aquabeam system, lot number 18c00144, which confirmed that there were four (4) other similar events that have been reported on this system.The aquabeam system's instructions for use (ifu), ifu320301, rev.D, was reviewed and bleeding is listed as a potential perioperative risk of the aquablation procedure.The system was not returned for investigation of this complaint.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.
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