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Catalog Number QD8 |
Device Problems
Overheating of Device (1437); Defective Device (2588); Naturally Worn (2988)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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Initial reporter's phone number: (b)(6).The device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and found that the attachment device had worn bearings.It was noted that the connection to the shaft was defective, that housing was hot, and the bearing and sleeve were damaged and worn.The assignable root cause was due to worn out bearings.This is further defined as wear from normal use and servicing over time.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Event Description
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It was reported by (b)(6) that during service and evaluation, it was observed that the attachment device had worn bearings.It was noted in the service order that the connection to shaft was defective, housing was hot and the bearing and sleeve were damaged and worn.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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Search Alerts/Recalls
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