The aquabeam handpiece was not returned for investigation of the reported event.A review of the device history record (dhr) for aquabeam robotic system / serial number (b)(6) and the aquabeam handpiece / lot number 23c04634 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 failure.The lot was segregated and affected units were reworked and re-inspected as part of our handpiece final inspection process.Upon re-inspection, the lot met all required specifications and was deemed acceptable to be released for distribution.The current user manual, sj-um0101-00 rev.B aquabeam robotic system user manual, 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.The root cause of the reported event was unable to be established as the device was not returned for investigation.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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