Device was used for treatment, not diagnosis.(b)(6).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the device failed pretest for handpiece temperature assessment (mentioned as 0), noise assessment, rotational speed assessment, motor thermistor assessment and loctite & cable assessment.Additionally, it was noted that the device displayed an e8 error code on the display and the motor and control were defective.Therefore, the reported condition was confirmed.The assignable root cause could not be determined.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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It was reported from (b)(6) that during an unspecified surgical procedure it was observed that the motor device was not working.It was not reported if there was a delay in the procedure due to the event, or if a spare device was available for use.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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