It was reported that, during a navio ukr procedure, there was an error message during calibration, the burr did not retract and the snap seemed locked.They took another handpiece to continue the procedure with a delay of fewer than 30 minutes.A the end of the surgery, the faulty handpiece was checked and it passed the test.This was the first of two incidents.There was no injury to the patient.No other complications were reported.
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H3, h6: the navio handpiece, part pfsr110137 used for treatment was not made available to the designated complaint unit for evaluation thus, a visual and functional evaluation could not be performed.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.Although the reported problem was not confirmed, a contributing factor may be mechanical component failure.No containment or corrective actions are recommended at this time.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.
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