Catalog Number 5400300000 |
Device Problems
Overheating of Device (1437); Smoking (1585)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/26/2014 |
Event Type
malfunction
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Event Description
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It was reported that during a procedure at the user facility the core impaction drill overheated and smoke came out of the tip of the device.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 procedure at the user facility, the core impaction drill overheated and smoke came out of the tip of the device.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 unable to confirm the reported events but noted that the motor assembly was corroded.
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Search Alerts/Recalls
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