Device was used for treatment, not diagnosis.The device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.The device was evaluated and the reported condition was confirmed.The assignable root cause was determined to be due to premature wear.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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It was reported from (b)(6) that during service and evaluation, it was determined that the bearing of the handpiece device was not functioning and was defective.It was noted that the bearing was faulty and creating heat.It was further determined that the device failed pretest for check of free movement.It was noted in the service order that the device was not working.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 the event was not reported, however, it was reported that the event occurred in 2018.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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