(b)(4).(b)(6).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was confirmed.The assignable root cause was not determined.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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It was reported by (b)(6) that during service and evaluation, it was discovered that the motor device had damaged component to the bearings/corrosion and was too loud.It was further determined during the pre-repair diagnostics assessment that the device failed for initial rotational speed and for noise verification.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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