The aquabeam handpiece was returned for an investigation into the reported event.No visual defects or anomalies were observed with the handpiece.Functional testing was able to reproduce the reported e22 during the first docking cycle and during the middle of the procedure.The handpiece was deconstructed and viewed under magnification.No signs of fluid ingress were observed on the encoder wheel or sensor board.How the handpiece triggered the e22 remains undeterminable.A review of the device history record (dhr) ab2000-b / serial number (b)(6) and aquabeam handpiece / lot number 22c02824 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 current user manual um0101-00 rev.F, aquabeam robotic system user manual, us, english was reviewed.Table 5 system detected errors and faults e22 - motorpack error release foot pedal and click x.1) if error persists, reconnect handpiece to motorpack.2) if error continues, replace handpiece.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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