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.The assignable root cause was undetermined.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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It was reported by (b)(6) that during service and evaluation, it was observed that the handpiece device blades were damaged, low power, and the hose had a hole.It was noted in the service order "motor low torque strength, noisy, nose was broken".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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