Additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Correction: the device manufacture date was incorrectly documented as sep 21, 2015 in the initial report.It has been updated as sep 21, 2010 to reflect the correct information.Device evaluation: the actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was not confirmed or duplicated.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that the device made an unusual noise, got very hot, trigger was sticking, the electric motor was damaged (heating up), the oscillating head and trigger parts were worn, and the set screw, bearings and straining ring were damaged as well.The assignable root cause was determined to be due to normal wear from use over time.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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