Catalog Number 5400300000 |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/19/2014 |
Event Type
malfunction
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Event Description
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It was reported that during a third molar case at the user facility the core impaction drill was overheating.The procedure was completed successfully using back-up equipment without a clinically significant delay; no medical intervention and no adverse consequences were reported.
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Manufacturer Narrative
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Failure analysis is in progress; additional information will be submitted once the quality investigation is completed.
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Event Description
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It was reported that during a third molar case at the user facility, the core impaction drill was overheating.The procedure was completed successfully using back-up equipment without a clinically significant delay; no medical intervention and no adverse consequences were reported.
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Manufacturer Narrative
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The technician was able to duplicate the reported event and noted that the driveshaft bearing was damaged.
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Search Alerts/Recalls
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