A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procep) became aware that post aquablation procedure the patient is experiencing incontinence.Per manufacturer instructions for use, incontinence or overactive bladder is a potential risk of the aquablation procedure.No malfunction of the aquabeam robotic system was reported during this event.Procept has requested addtional information on this event, which includes any course of action taken to address the reported incontinence.
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The aquabeam robotic system was not returned for investigation of this event and it is currently in use at the user facility.The investigation consisted of review of the information provided, plus a review of the treatment log files, device history record (dhr), and product's labeling.The aquabeam robotic system's treatment log files were 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) for ab2000-b/serial number (b)(6) was performed, which confirmed that there were no nonconformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.The review indicated that the device met all design and manufacturing specifications when released for distribution.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: incontinence or overactive bladder.A root cause for the reported event could not be determined.Through additional information by procept, it was confirmed that the patient has made a full recovery.The aquabeam robotic system instructions for use list incontinence or overactive bladder as a potential risk of the aquablation procedure.Based on the review of the treatment log files, dhr and ifu this event is considered not to be device-related.
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