(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 confirmed.However, the assignable root cause could not be determined.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 bearings were damaged, the engine and control were defective, the device was becoming hot, the power was too low, the connector sleeve cable was defective and the marking was absent on the motor device.It was also observed that the temperature on the device reached the maximum speed after thirty seconds (maximum speed of hand regulator is 72000).The device also failed the following pre-tests: temperature assessment and hand control 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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