The aquabeam handpiece was not returned for investigation of the reported event as it was disposed of.The current user manual um0101-00 rev.F, aquabeam robotic system user manual, us, english, 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.A review of the device history record (dhr) for aquabeam robotic system/serial number (b)(6) and the aquabeam handpiece / lot number (b)(6) was performed, which confirmed that there were no non-conformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.The review indicated that the system met all design and manufacturing specifications when released for distribution.A review of the treatment log files confirmed the reported e22 error; however, 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.
|