The aquabeam handpiece was not returned for investigation of the reported event.Three (3) good faith efforts were made to retrieve the device without success.The treatment log files were reviewed.No occurences of "e21 - motorpack" errors were observed; however, multiple "e22 - motorpack" and "e23 - motorpack" errors were observed to have occurred.The root cause of the reported event was unable to be established as the device was not returned for investigation.A review of the device history record (dhr) for aquabeam robotic system/serial number (b)(6) and the aquabeam handpiece / lot number 23c10522 was performed, which confirmed that there was one (1) non-conformance issued to this lot during the manufacturing process that could potentially be related to the reported event.The affected units within the lot were segregated and reworked to address the non-conformances.The handpiece passed final inspection prior to release for distribution.The current user manual sj-um0101-00 rev.B, um, aquabeam robotic system user manual, us, baytech was reviewed and states: table 5: system detected errors and faults: e21 - motorpack error.Release foot pedal and click x.If error persists, replace motorpack.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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