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.This complaint was initially entered as a unit heating up with low water flow but it was revealed during the evaluation that the handpiece was also heating up, making it a reportable case.Even though the aware date is 01/03/2024, the case was deemed reportable after product evaluation on 3/12/2024 which becomes the new aware date for reportability.Investigation findings notes: march 12, 2024 repair tech: gpb qa: mo foot pedal serial number-current-(b)(6) handpiece/sterimate lot number-current-2022053 handpiece cable lot number-current-05220 root cause: w4h water sol,iso valve damaged ********************************************* debris buildup in the water solenoid causing poor water flow and the water solenoid was also not holding manufactured standard pressure heavy debris buildup in the water filter ********************************************* note: replaced damaged/worn components and recalibrated unit to factory specs.********************************************* additional notes: water solenoid had debris build up and heavy debris build up in the water filter which was leading to low water flow during testing the unit.This would be the reason why the handpiece/sterimate was heating up.
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