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 labeling.The dhr review cannot be conducted as the lot number of the ab2000 system is unknown.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: - urethral damage causing false passage or stricture - urinary retention a root cause for the reported event could not be determined.The aquabeam robotic system instructions for use list urethral damage causing false passage or stricture and urinary retention as a potential risks 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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A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that one month post-aquablation procedure, the patient experienced a severe urethral stricture at the fossa, which required emergency intervention as he was unable to urinate.No malfunctions of the aquabeam robotic system were reported.Please note that this report is related to the voluntary report under mw5150221.
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