A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that after the first treatment pass, the treating surgeon noted that the patient's left ureteral orifice (uo) was inflamed.Out of an abundance of caution, a ureteral stent was placed in the patient's left uo.The patient is reportedly doing well with no further issues.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 procept's risk documentation.A review of the device history record (dhr) ab2000-b/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.Although the aquabeam robotic system labeling does not specifically mention damage to ureteral orifices, procept's risk management documentation includes damage to ureteral orifices as a clinical effect of the aquablation procedure.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 risk documentation , 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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