A review of the aquabeam robotic system's log file was conducted, which confirmed that there were no malfunctions related to the reported event.The review indicated that the system functioned as designed.A review of the device history record (dhr) was conducted for lot number 19c00345, 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 specifications when released for distribution.A review of similar complaints was conducted on lot number 19c00345, which confirmed that there were four (4) other similar events reported on this lot.The aquabeam robotic system's instructions for use (ifu), ifu320301, lists potential perioperative risks of the aquablation procedure.A root cause for the reported event could not be determined.Based on review of the log file, dhr and ifu, the event is considered not to be device related.
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