(b)(4).Reporter's phone number was not provided.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 improper maintenance, which is user error/misuse/abuse.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
|
It was reported by (b)(6) that the compact air drive device motor had seized, jammed and was heavy moving.During service and evaluation, it was noted that the motor was found blocked.It was also noted that the device failed pre-repair diagnostic tests for status of development, function of the triggers for fwd / rev mode, untrue running, the power with test bench, starting behavior, air leak, the function of soft mode switch (safety system), and excessive noise.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.
|