The aquabeam handpiece was not returned for investigation of the reported event.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 24c11890 was performed, which confirmed that there were two (2) non-conformances 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 aquabeam robotic system user manual, um0101 rev.F, states the following: 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.E23 - motorpack error: release foot pedal and click x.1) if error persists, reconnect handpiece to motorpack.2) if error continues, replace handpiece.E31 - motorpack error: release foot pedal and click x.If error persists, 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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