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Catalog Number QD11 |
Device Problems
Defective Device (2588); Temperature Problem (3022)
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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)(4).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and observed that the device had a cosmetic defect and was getting too hot due to the damaged casing.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to worn out bearings from normal use and servicing over time.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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Event Description
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It was reported by the (b)(6)that during service and evaluation, it was observed that the attachment device had a cosmetic defect.It was also noted that the device was getting too hot due to the damaged casing.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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