(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 improper reprocessing, which is user error/misuse/abuse.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 during service and evaluation, it was observed that the motor device had damaged component - cable/cord/wiring and liquid damage.It was further determined that the motor, control, hose and coupling were all defective.It was further determined that the device first displayed e09 then e08; and 118 degrees fahrenheit after "2' 40".It was further determined that the device failed pre-test for loctite and cable assessments, rotational speed assessment, handpiece temperature assessment and air pump 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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