(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.
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It was reported by (b)(6) that the attachment device was not working properly.During the pre-repair diagnostics assessment, it was determined that the bearings were worn.It was further observed that the glue to the sleeve and the screw to the thimble were loose.It was further determined that the bearings in the housing become hot and the device had strong vibration.It was further determined that the device failed for nose tube assembly, thimble set screw, vibration and for temperature 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.
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