A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that post-aquablation therapy, a small laceration was noted at the patient's bladder trigone.No medical intervention was needed to manage the small laceration.One day post-aquablation procedure, the patient was reported to be doing well with a clear foley balloon catheter.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 device history record (dhr), and labeling.A review of the device history record (dhr) for ab2000-b/serial number (b)(6) was performed, 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 device 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 or prostate capsule perforation.A root cause for the reported event could not be determined.It was reported that post-aquablation therapy, a small laceration was noted at the patient's bladder trigone.No medical intervention was needed to manage the small laceration.The aquabeam robotic system's ifu lists bladder perforation as a potential risk of the aquablation procedure.Based on the event details plus a review of the 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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