(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 determined to be due to wear from normal use and servicing.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
|
It was reported by (b)(6) that the motor device was submitted for maintenance.During the pre-repair diagnostics assessment, it was determined that the cable/cord/wiring was damaged and the motor and control were defective.It was further determined that the clutch was worn and the device was getting hot.It was further determined that the device failed for handpiece temperature assessment, motor thermistor assessment, hand control assessment and for safety assessment.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.
|