A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that post-aquablation treatment, a minor mucosal injury located in the urethra adjacent to the external sphincter was noted.The treating surgeon was unable to determine whether the injury occurred during aquabeam handpiece manipulation or with the resectoscope during hemostasis.A foley balloon catheter was placed per typical post-operative protocol, and no additional catheterization time was required as a result of this event.No malfunction of the aquabeam robotic system was reported.
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The aquabeam robotic system is a reusable device; therefore it is currently in the possession of the user facility.The investigation of this event consisted of a review of the device history record (dhr) and instructions for use (ifu).A review of the device history record (dhr) (b)(4) /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: urethral damage causing false passage or stricture.The aquabeam robotic system is a reusable device; therefore, it is still currently in possession of the user facility.The aquabeam robotic system's ifu lists urethral damage as a potential risk of the aquablation procedure.Based on the event details and 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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