A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that post-aquablation therapy and following removal of the aquabeam handpiece from inside the patient, the treating physician observed a significant intravesical lobe laying on the posterior aspect of the bladder wall; thereby, the area was resected with a loop.During resection, the back of the bladder wall was perforated and later confirmed with a ct scan.Following confirmation from the ct scan, the patient was opened up to close the perforation.Procept confirmed with the treating physician that the patient is healed and is doing well.No malfunction of the aquabeam robotic system was reported.Per the manufacturer's instructions for use, bladder perforation is a perioperative risk of the aquablation procedure.
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H.10 additional manufacturer narrative: the aquabeam robotic system was not returned for investigation of this event and is currently in use at the user facility.The investigation consisted of a review of the information reported to procept, plus a review of the event log files, device history record (dhr), and labeling.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: o bladder perforation.A root cause for the reported event could not be determined.The aquabeam robotic system instructions for use lists bladder perforation as a potential risk of the aquablation procedure.Additionally, per the event details, the bladder injury occurred during hemostasis and post-aquablation therapy.Based on the event details plus review of the treatment log files, dhr, and ifu the event is considered not to be 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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