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Model Number G124 |
Device Problems
Restricted Flow rate (1248); Sparking (2595); Noise, Audible (3273)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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There has been a previous report received where lack of water flow has caused an overheating insert.Since an overheating insert could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur.As such, this event meets the criteria for reportability per 21 cfr part 803.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.
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Event Description
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While using a g124 scaler, there was no water flow, the unit was making a fast clicking noise, and there were sparks coming out of the back of the unit; no injury resulted.
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Manufacturer Narrative
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Evaluation found the universal board was defective.
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Search Alerts/Recalls
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