The aquabeam handpiece was returned for investigation.Functional testing was able to replicate the e22 error.The root cause of the reported error is undeterminable.A review of the device history record (dhr) ab2000-b / serial number (b)(6) and aquabeam handpiece / lot number 23c10015 was conducted, which confirmed that there were five (5) 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 investigation into this issue has confirmed the occurrence of "e22 - motorpack" errors.The issue is being addressed through procept's quality system.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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