(b)(4).(b)(6).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to improper handling.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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It was reported from (b)(6) that during service and evaluation, it was determined that the motor on the device housing was damaged and cracked.It was further determined that the device failed pretest for check response of on/off trigger, check function of all modes, check fitting of the lids, check falling out protection (steal ring), check proper function of the triggers and check for leakage and general condition.It was noted in the service order that the device was unable to function.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 will be submitted accordingly.
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