A review of the aquabeam robotics system's conformal planning unit (cpu) log file confirmed no malfunctions related to the reported event.The review of the cpu log file indicated that the system functioned as designed.A review of the device history record (dhr) for the aquabeam robotics system, lot number 19c00548, 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 19c00548, confirmed that there is one (1) other similar event that has been reported on this system.The aquabeam robotic system's instructions for use (ifu), ifu320301, rev.D, 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 a potential risk of the aquablation procedure.Based on the review of the cpu log file, dhr, and ifu, the event is considered not to be device related.
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A male patient underwent aquablation procedure.It was reported that approximately an hour post procedure, the patient's foley balloon catheter turned red (per manufacturer's instructions for use bleeding is a potential perioperative risk of the aquablation procedure); therefore, the patient was taken back to the operating room (or) where a large vessel was found in the prostatic fossa.This had not been previously detected during clot evacuation and cautery post-aquablation procedure.The physician proceeded to perform cauterization of the patient.The patient was reported to be in good condition post-cauterization.No further sequela was reported.No malfunction of the aquabeam robotic system was reported.
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