A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that post-aquablation procedure the patient showed symptoms of urinary retention (per manufacturer's instructions for use, urinary retention is a perioperative risk of the aquablation procedure).The aquablation procedure was successfully completed.On (b)(6) 2020, the patient underwent a transurethral resection (tur).No adverse health consequences or sequela were reported to have occurred with the patient.No malfunction of the aquabeam robotic system was reported.
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H.10 additional narrative/data: a review of the aquabeam robotic system's log file was reviewed, which confirmed no malfunctions during the aquablation procedure.The review indicated that the system functioned as designed.A review of the device history record (dhr) serial number (b)(6) was conducted, which confirmed that there were no nonconformances generated during the manufacturing process of this system.The review indicated that the system met all required specifications upon release for distribution.A review for similar complaints was performed on serial number (b)(6), which confirmed that there were no other similar events.There are no other similar events reported across all other systems.The aquabeam robotic system's instructions for use (ifu), ifu0104-00, rev.A, 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 urinary retention.A root cause for the reported event could not be determined as the product was not returned for investigation.Urinary retention is a potential risk of the aquablation procedure.Based on the review of the log file, 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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