(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 duplicated and confirmed.The assignable root cause was determined to be due to improper handling, 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 from (b)(6) that during service and evaluation, it was observed that the motor device hose was wornout, the device had liquid damage, the motor and control were defective, the coupling was wornout, the device was noisy and the device was hot.It was further determined that the device failed the following pre-tests: loctite and cable, handpiece temperature, noise, safety and air pump assessments.It was reported in the service order that the device had a hole in the middle of the hose.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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