(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 austria that the compact air drive device had an undetermined malfunction.During service and evaluation, it was observed that the compact air drive device motor power was too low.It was also noted that the device failed pre-test for air hose coupling, air leak, function of soft mode switch (safety system), excessive noise, power with test bench: min.110 to 160 w, and starting behavior.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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