(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 sweden that the motor device had an undetermined malfunction.During service and evaluation, it was observed that the motor device had excessive noise level - (db), the motor and bearings were worn out and the connector was loose.It was further noted that the device failed pre-test for loctite and cable assessments, noise assessment and safety assessment.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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