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 19c00119, 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 19c00119, which confirmed that there were no other similar events reported on this lot.The aquabeam robotic system's instructions for use, ifu310301, was reviewed and "bleeding" is listed as a potential perioperative risk of the aquablation procedure.A root cause for the reported event could not be determined.Bleeding is an anticipated perioperative risk of the aquablation procedure.Based on review of the log file, dhr and ifu, the event is considered not to be device related.
|
It was reported that post an aquablation procedure, a patient was taken back to the operating room (or) to remove clotting that had collected in the bladder, blocking one of the patient's urethral openings.The patient was discharged from the hospital four (4) days post the aquablation procedure and was doing fine.No further sequela was reported.There was no malfunction of the aquabeam robotic system observed during the procedure.
|