DENTSPLY PROFESSIONAL CAVITRON JET SPS ULTRASONIC SCALER AND AIR POLISH SYSTEM; SCALER, ULTRASONIC
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Model Number G120 |
Device Problems
Overheating of Device (1437); No Flow (2991); Temperature Problem (3022)
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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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While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr 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 using a g120 scaler, the unit has no water flow and the inserts are getting hot; no injury resulted.
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Manufacturer Narrative
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Evaluation found unit to have restricted water flow, add new water solenoid, water regulator and viton tubing, major corrosion on the main air manifold and handpiece cable had exposed outer covering of the handpiece cable.
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Search Alerts/Recalls
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