(b)(4).(b)(6).The 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 device wear from normal use and servicing.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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It was reported by (b)(6) that the handpiece hose on the motor device ruptured.During service and evaluation, it was determined that the hose had a cut/hole and was worn.It was further determined that the device was too loud and had sluggish bearings.It was further determined that the device failed pretest for outer hose inspection, sound, oil leak and rpm.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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