On (b)(6) 2022, a 79-year-old patient reported to procept biorobotics corporation (procept) having undergone an aquablation procedure for symptomatic benign prostatic hyperplasia (bph) on (b)(6) 2022.In the recovery room, the patient's abdomen started getting full, which was indicative of fluid getting outside of the bladder.The patient was taken back to the operating room (or) for a bladder perforation requiring surgical repair.The patient was discharged home and recovering well.Per the manufacturer's instructions for use, bladder perforation is a potential 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 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: o bladder or prostate capsule perforation.It is unknown whether the bladder perforation occurred during the aquablation procedure or during hemostasis with a resectoscope.The aquabeam robotic system's ifu lists bladder perforation as a potential risk of the aquablation procedure.No malfunction of the aquabeam robotic system was reported by the treating physician during this event.The root cause of the reported event was unable to be determined.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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