Catalog Number 8800005 |
Device Problems
Restricted Flow rate (1248); Overheating of Device (1437)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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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.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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While the customer was using a cavitron integrated system built in ultrasonic scaler g139 they allege that the tip is overheating.No injury was reported from the alleged event.
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Manufacturer Narrative
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W2e reg, needle valve, hp flow control clogged hp cable and hp received for evaluation.No fault found with the unit but the inline water regulator is partially clogged getting insufficient water flow thru the hp causing the tip not to get cool enough.The regulator needs to be replaced.
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Search Alerts/Recalls
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