The patient, who underwent the aquablation procedure more than a year ago, has informed procept biorobotics corporation (procept) about experiencing challenges in achieving and sustaining erections at the same level as before.Despite trying conventional erectile dysfunction (ed) medications, the patient's performance has not returned to its previous state (per manufacturer instructions for use, sexual dysfunction, including ejaculatory and erectile dysfunction are potential perioperative risks of the aquablation procedure).The patient has been advised to consider the alma duo procedure as an alternative option.
|
Procept biorobotics corporation has been in contact with the patient and no further information is available at this time.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 labeling.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 and states the following: 4.3.Warnings: procedure: as with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: sexual dysfunction, including ejaculatory and erectile dysfunction.The aquabeam robotic system is a reusable device; therefore, it is still currently in possession of the user facility.The device was not returned for investigation because it performed as intended during the aquablation procedure and was confirmed through our investigation of the event.The aquabeam robotic system's ifu lists sexual dysfunction, including ejaculatory and erectile dysfunction as a potential risk of the aquablation procedure.Based on the 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.
|