(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 not working properly.During the pre-repair diagnostics assessment, it was determined that there was component damage to the cable/cord/wiring.It was further determined that the motor and control were defective, the clutch was worn out, and the device was getting hot and was too loud.It was further determined that the tooling was not functioning and was rotating.It was observed that the hose did not seem to be air tight.It was further determined that the device failed for handpiece temperature assessment, noise 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.
|