Additional info: d10, d11, g4, g7, g9, h2, h3, h6, h10.Results of investigation: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional evaluation could not be performed.Dhr review found that the reported product met manufacturing specifications prior to being released for distribution.A complaint history review found similar reports, this issue will continue to be monitored.This failure is an identified failure mode within the risk file.The navio surgical technique guide released at the time of the complaint ((b)(4)) provides instructions for separating the handpiece from the point probe and for how to recover to a fully manual procedure in the case the of a navio surgical system failure at any point during the surgical case.A relationship, if any, between the subject device and the reported event could not be determined.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.No further medical assessment is warranted at this time.
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