A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procep) became aware that post aquablation procedure, and during hemostasis, a prostatic capsule perforation occurred with the resectoscope.In response to the prostate capsule perforation, the surgeon left a foley balloon catheter in place longer to allow healing of the perforation.No malfunction of the aquabeam robotic system was reported during this event.Per the manufacturer's instructions for use, prostate capsule 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.The aquabeam robotic system's treatment log file was reviewed, which confirmed no malfunctions during the aquablation procedure.The review of the treatment log file indicated that the system functioned as designed.A review of the device history record (dhr) ab2000-b rev.G/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's 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: prostate capsular perforation.5.6 precautions: procedure when in the transverse trus view, ensure the resection angle is not set beyond the prostate capsule.When in the sagittal trus view, ensure the contour does not extend beyond the desired resection region.Failure to do so may result in prostatic capsule perforation.A root cause for the reported event could not be determined.A review of the event log files was not conducted as these were not available.Prostate capsular perforation is a potential risk of the aquablation procedure.Based on the information received, plus the 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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