On (b)(6) 2023, a male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).On 31-oct-2023, procept biorobotics corporation (procept) became aware that following the aquablation procedure, the patient's symptoms had returned and subsequently underwent a greenlight laser therapy in (b)(6) 2023.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 instructions for use (ifu).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: 5.Precautions; 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.The aquabeam robotic system is a reusable device; therefore it is currently in the possession of the user facility.Per the aquabeam robotic system instructions for use, 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.Based on the review of the information obtained plus a 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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