Model Number G137-14412 |
Device Problems
Overheating of Device (1437); Temperature Problem (3022)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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While using a g137 scaler, the inserts were heating up; no injury resulted.
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Manufacturer Narrative
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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 803.803.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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Manufacturer Narrative
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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 803.803.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 g137 scaler, the inserts were heating up; no injury resulted.
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Manufacturer Narrative
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Multiple unsuccessful attempts were made to obtain the device for evaluation.
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Search Alerts/Recalls
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