H6: health effect - clinical code 4581 - lower urinary tract symptoms (luts) are a common complaint among aging men.These symptoms are often caused by benign prostatic hyperplasia (bph), and include nocturia, urinary frequency, urgency, decreased urine flow rates, incomplete bladder emptying, and hesitancy.The aquabeam robotic system is a reusable device; therefore, it is still currently in 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) for 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 device met all design and manufacturing specifications when released for distribution.The aquabeam robotic system instructions for use (ifu) - japan, ifu0107-00, rev.A, was reviewed and states the following: 5.1 precautions: general.No claim is made that the aquabeam robotic system will cure any medical condition or entirely eliminate the diseased entity.Repeated treatment or alternative therapies may sometimes be required.A root cause for the reported event could not be determined.The aquabeam robotic system does not guarantee the cure of any medical condition or entire elimination of diseased entity.Repeated treatment or alternative therapies may sometimes be required.Based on the event details plus a review of the dhr and labeling, 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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On (b)(4) 2023, a male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that post-aquablation therapy, the patient had presented with lower urinary tract symptoms which were treated with medication.The patient's lower urinary tract symptoms have not resolved.The event was reported to be mild and serious.The treating surgeon reported that this event was related to the aquablation procedure.No malfunction of the aquabeam robotic system was reported.
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