(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 duplicated and confirmed.The assignable root cause was determined to be due to normal wear from use and servicing over time.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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It was reported from netherlands that during service and evaluation, it was discovered that the compact air drive device motor had seized, was jammed, heavy moving, the motor shaft and push button were worn, the rotary knob did not function properly and the casing was damaged.It was also observed that the device failed the following pre-tests: general condition, check the attachment coupling, check attachment coupling with attachments, check function of soft mode switch (safety system), check for excessive noise and check starting behavior.The event was not related to surgery.There was no patient involvement reported.There were no injuries, delays, or medical intervention associated with this event.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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