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.
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Based on the repair evaluation of the g137 scaler, the regulator needle valve, & hp flow control was loose, the lavage knob was loose, unable to regulate water flow; low/no water flow causing jetmate to heat up; no injury resulted.
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