Component code = 4756 - aquabeam console, a reusable component of the aquabeam robotic system, controls the functionality of the high-velocity waterjet delivered by the aquabeam handpiece.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 console was returned for investigation.Functional testing was able to replicate the e02 and e03 errors.Additional analysis observed oil droplets on the encoder sensor and was identified to be the main cause of the e02 and e03 issues.A review of the device history record (dhr) ab2000-b / serial number (b)(6) and aquabeam console / lot number 23c02109 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 system met all design and manufacturing specifications when released for distribution.The current user manual, um0101-00 rev.F aquabeam robotic system user manual, states: table 5 system detected errors and faults e02 - console error.Release foot pedal and click x.If error persists, turn off and turn on console.E03 - console error.Release foot pedal and click x.If error persists, turn off and turn on console.The root cause of the reported event has been determined to be due to manufacturing related issues associated with a third party supplier.The reported 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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