Catalog Number G137 |
Device Problems
Restricted Flow rate (1248); Overheating of Device (1437); No Flow (2991)
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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 cavitron jet plus g137, they allege that they have minimal water and the handpiece is heating up, no injury resulted.
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Manufacturer Narrative
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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 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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Manufacturer Narrative
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Root cause: emh hp;cable,conn/gun cable damaged.Debris buildup in the handpiece cable and leaking water around the water turn knob continuous water leaking due to debris buildup in the water system not allowing the solenoid to close completely.Jet-mate has a bent contact pin.Manifold has bad regulation resulting in inconsistent powder flow.Cracked powder bowl (has a different screw that is going through the top cover of powder bowel).Baffle is damaged.No operation with the wireless foot pedal.No powder flow due to a clogged y-fitting.Debris build in the water filter.Note: will replace damaged/worn components and recalibrate unit to factory specs upon estimate approval.(this unit looks like it has been previously open and worked on).
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Search Alerts/Recalls
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