H.10 additional manufacturer narrative: h.6 adverse event problem component code 4756: per the instructions for use, the aquabeam motorpack, a re-usable component of the aquabeam robotic system, provides power to the aquabeam handpiece by means of dc motors.Root cause of reported event has not yet been established.Investigation by manufacturer is currently in-process.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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The aquabeam motorpack was not returned for investigation of the reported event.A replacement aquabeam handpiece was provided to the account as part of warranty replacement.Three (3) good faith efforts to retrieve the device were made without success.The root cause of the reported issue is unable to be determined as the aquabeam motorpack was not returned for investigation.A review of the device history record (dhr) for aquabeam robotic system/serial number (b)(6) and the aquabeam motorpack / lot number 21c01258 was conducted, 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 device met all design and manufacturing specifications when released for distribution.The current user manual um0104-00 rev.G, aquabeam robotic system user manual, intl (ce), english was reviewed and states the following: table 5: system detected errors and faults e50 - console error release foot pedal and click x.If error persists, turn off and turn on console and cpu.11.2.3 non-sterile: console, motorpack, and foot pedal connection connect the motorpack cable to the front of the console: connect the motorpack plug on the front right port.Ensure the connector locks in place and the red marks on the motorpack and the console align submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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