A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that, after two treatment passes, upon introducing the resectoscope into the patient's bladder, a bilateral disruption of the posterior bladder wall near the trigone was observed, measuring approximately 1cm in length, and with sporadic spots.The patient's vitals were reported to be normal throughout the aquablation procedure.Following the standard continuous bladder irrigation (cbi) protocol, the patient was discharged from the hospital per the usual procedure.The treating surgeon confirmed that there was no perforation of any kind but was uncertain about the cause of the bladder disruption.Upon a follow-up conversation and investigation procept determined that the waterjet contour plan used during the aquablation procedure did not appear to be in proximity to the noted bladder disruption.Additionally, no reasons for the disruption were found related to the aquablation procedure planning.While it was reported that the patient had a previous transurethral resection of the prostate (turp), it cannot be conclusively established that it caused the bladder disruption.No malfunction of the aquabeam robotic system was reported.
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The aquabeam robotic system is a reusable device; therefore, it is still currently in possession of the user facility.The investigation of this event consisted of a review of the treatment log files, device history record (dhr), and labeling.The aquabeam robotic system's treatment logs file was reviewed, which confirmed no malfunctions during the aquablation procedure.The review of the treatment logs indicated that the system functioned as designed.A review of the device history record (dhr) ab2000-b / serial number (b)(6) was conducted, which confirmed that there were no non-conformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.The review indicated that the system met all design and manufacturing specifications when released for distribution.The aquabeam robotic system instructions for use (ifu), ifu0101-00, rev.E, was reviewed and states the following: 4.3 warnings: procedure: · as with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: - bladder or prostate capsule perforation.The aquabeam robotic system was not returned for investigation of this complaint.The treating surgeon confirmed that there was no perforation of any kind, but was uncertain about the cause of the bladder disruption.The waterjet contour plan used during the aquablation procedure did not appear to be in proximity to the noted bladder disruption.Additionally, no reasons for the disruption were found related to the aquablation procedure planning.No malfunction of the aquabeam robotic system was reported during this event.Based on the information obtained through the treating surgeon plus a review of the treatment log files, dhr, and labeling the event is considered not device-related.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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