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 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 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 or prostate capsule perforation.A root cause of the reported event could not be determined.The aquabeam robotic system instructions for use lists bladder or prostate capsule perforation as a potential risk of the aquablation procedure.Based on the information received, plus a review of the treatment logs, ifu and dhr, 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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A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that during aquablation therapy, the treating surgeon unintentionally resected over the patient's left ureteral orifice, which was confirmed via x-ray imaging.A stent was placed to treat the ureteral orifice injury and the patient was discharged.No malfunction of the aquabeam robotic system was reported.
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