The aquabeam handpiece was returned for investigation of the reported event.No visual defects or anomalies were observed with the handpiece.Functional testing was performed on the reported handpiece, but no issues were observed, and the handpiece functioned as expected.Further investigation observed no signs of fluid ingress on the sensor board and the encoder wheel.Root cause is undeterminable as reported failure mode could not be reproduced upon receipt.A review of the device history record (dhr) ab2000-b / serial number (b)(6) and aquabeam handpiece / lot number 23c02072 was conducted, 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 reworked to address the nonconformance.Upon re-inspection, the lot met all required specifications and was then deemed acceptable to be released for distribution per device specifications.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 submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
|