Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition was confirmed.The assignable root cause was determined to be traced to user, which is user error.Udi: (b)(4).
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It was reported by (b)(6) that during service and evaluation, it was determined that the flex circuit, cable, and locking components of the motor device were damaged.It was further observed that the device generated heat and excessive noise.It was further determined that the device failed pretest for visual assessment, cable assessment, motor thermistor assessment, air pump assessment, noise assessment and handpiece temperature assessment.It was noted in the service order that the connector part of the device had a failure.This event did not occur during surgery.There was no patient involvement.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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