DENTSPLY PROFESSIONAL MIDWEST E PLUS 1:5 HIGHSPEED ATTACHMENT; HANDPIECE, BELT AND/OR GEAR DRIVEN, DENTAL
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Catalog Number 875205 |
Device Problem
Overheating of Device (1437)
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Patient Problems
Burn(s) (1757); Burn, Thermal (2530)
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Event Type
malfunction
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Manufacturer Narrative
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Though no medical/surgical intervention was required to preclude a serious injury in this event, there have been previously reported events involving a similar device that resulted in the need for medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function.Therefore, this event meets the criteria for reportability per 21 cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
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Event Description
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In this event, a doctor reported that a midwest e plus1:5 attachment overheated and burned a patient's lip.There was no intervention required.
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Manufacturer Narrative
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Evaluation found bur bearing damaged/ bearing debris in head from failed bur bearing.Cap also has rotor mark on cap.Replaced turbine and new cap.Cleaned water port, replaced water tubes.
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Search Alerts/Recalls
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