A review of the aquabeam robotics system's log file confirmed no malfunctions related to the reported event.The review of the log file indicated that the system functioned as designed.A review of the device history record (dhr) for the aquabeam robotics system, lot number 19c00394, 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 complaints on the aquabeam robotics system, lot number 19c00394, confirmed that there were no other similar events reported on this system.The aquabeam robotic system's instructions for use, ifu320301, was reviewed and prostate capsule perforation is listed as a potential perioperative risk of the aquablation procedure.The system was not returned for investigation of this event.A root cause for the reported event could not be determined.Prostatic capsule perforation is an anticipated 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.
|
Male patient underwent an aquablation procedure.It was reported that during the aquablation procedure, perforation of the prostatic capsule on the left side occurred (per manufacturer's instructions for use, prostate capsule perforation is a potential perioperative risk of the aquablation procedure).The patient was discharged from the hospital five (5) days post-op and was reported to be in good condition.No further clinical sequela was reported.No other information was provided by the treating physician.
|