The aquabeam handpiece was returned for investigation.Functional testing was unable to reproduce the reported event, as the handpiece was able to successfully prime at 50% and 100% pump power and no issues were observed after a simulated waterjet alignment and full aquablation cycle.A flowrate test was conducted on the handpiece at low to high pump levels, which passed per product specifications.Additionally, the inlet valve was inspected under magnification and was observed to have no damages or defects.A review of the device history record (dhr) for serial number (b)(6) and the aquabeam handpiece / lot number 20c00634 was 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 component met all design and manufacturing specifications when released for distribution.A review of similar complaints confirmed one (1) other similar event reported to procept.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: a.Toggle the trus stepper cradle (if needed) to center the aquabeam handpiece hyperechoic artifact with vertical yellow line b.Press the foot pedal to visualize position of waterjet (retract trus probe if needed by using knobs on stepper) c.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 could not be established, as the in-house investigation found no problems with the returned device.The handpiece performed as intended.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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