The aquabeam handpiece was returned for investigation.Functional testing confirmed that the aquabeam handpiece was unable to prime, which in indicative to an issue with the inlet valve within the pump cartridge.The pump cartridge on the handpiece was disassembled and the inlet valve was removed.It was identified that the inlet valve was uneven from the side view as seen below and there were also flashes seen from the top view.A review of the device history records (dhr) for ab2000/serial number(b)(6) and aquabeam handpiece/lot number 20c00634 were performed, which confirmed that there were no nonconformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.The review indicated that the system and its associated components met all design and manufacturing specifications when released for distribution.The aquabeam robotic system instructions for use, ifu0104-00 rev.B, was reviewed and states the following: 8.23.Sterile: align waterjet nozzle by doing the following: toggle the trus stepper cradle (if needed) to center the aquabeam handpiece hyperechoic artifact with vertical yellow line press the foot pedal to visualize position of waterjet (retract trus probe if needed by using knobs on stepper) waterjet needs to be visible at 3 or 9 o'clock d.If slightly off, depress the black button on the mag block (located on the handpiece articulating arm) and rotate the aquabeam handpiece axis while stepping on foot pedal to align jets to 3 and 9 o'clock position.The root cause of the reported event has been identified to be related to a manufacturing process issue during the injection molding of the inlet valves by the supplier.Procept has identified a trend regarding no movement of the high-velocity waterjet on the aquabeam handpiece and has initiated a corrective action and preventive action to further investigate this issue.
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