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Catalog Number G310SCLR |
Device Problem
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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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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Event Description
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While using a cavitron 300 series g310, they allege that no water was getting to handpiece and the handpiece is getting hot, no injury resulted.
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Manufacturer Narrative
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The hpc is damaged, thereby preventing water flow, also damaging the st.There was no water running through the hpc to the st.The st was hot and got burnt.Debris in water filter, usb cable was corroded, thereby damaging the fc.Damaged parts have been replaced, unit have been calibrated and tested to factory's specs.No other faults found.Incorrect st was used when it got burnt.
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Search Alerts/Recalls
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