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Catalog Number QD8 |
Device Problems
Loose or Intermittent Connection (1371); Defective Device (2588)
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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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(b)(6).The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent 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 bearings were worn.It was noted in the service order "groove to thimble defective, missing bearing and sleeve is damaged.Splice sleeve is loose, vibrations at e - test".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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Manufacturer Narrative
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This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and found that the groove to thimble was defective, missing bearings and sleeve was damaged, splice sleeve was loose and the vibration during testing.Therefore, the reported condition was confirmed.The assignable root cause was due to normal wear.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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