A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that the patient had presented with ejaculatory dysfunction (per manufacturer instructions for use, sexual dysfunction, including ejaculatory and erectile dysfunction are potential perioperative risks of the aquablation procedure) and hematuria.It was reported that hematuria was treated with medication and catheterization, while the treating physician was to monitor the patient's condition for ejaculatory dysfunction.The physician determined that the ejaculatory dysfunction was related to the procedure and unlikely related to the device, and assessed the hematuria as related to the procedure and not related to the device.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 labeling.A review of the device history record (dhr) ab2000-c/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 treating surgeon confirmed that the aquabeam robotic system functioned as intended, and assessed the event to be related to the procedure.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.
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