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) - japan, ifu0107-00, rev.A, was reviewed and states the following: 4.3.Warnings: procedure: as with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include but are not limited to the following, some of which may lead to serious outcomes and may require intervention: incontinence or overactive bladder.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.The aquabeam robotic system user manual lists incontinence or overactive bladder as a potential risk of the aquablation procedure.Based on the event details 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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