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Catalog Number QD8 |
Device Problems
Break (1069); Corroded (1131); 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).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 confirmed.The assignable root cause was determined to be due to improper cleaning and maintenance, which is user error, misuse, and / or abuse.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 discovered that there was component damage to the bearings/corrosion on the attachment device.It was further determined that the device was dirty, the gears were corroded and defective and the tip and bearing were worn.It was further determined during the pre-repair diagnostics assessment that the device failed for temperature assessment.It was noted on the service order that the device was not functioning and did not hold the milling cutter device.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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