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Catalog Number 81324 |
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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Event Description
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While using a cavitron select sps g124 they allege that no water running and handpiece is hot, 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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Evz potentiometer shorted.Short in the power potentiometer causing the scale power to stay on highest level.Debris buildup in the water filter.Replaced damaged/worn components and recalibrated unit to factory specs.Qa-tl: could not duplicate the complaint of no water and the handpiece getting hot.Check your inserts for any damage or clogging.Make sure only 30k denstply sirona inserts are being used with this unit, any other brand can cause issues.Handpiece 01/2023, hdpc 12/2022.Notes: 04/11/24 repair tech: (b)(4).Evz potentiometer shorted.Short in the power potentiometer causing the scale power to stay on highest level.Debris buildup in the water filter.Replaced damaged/worn components and recalibrated unit to factory specs.Qa-tl: could not duplicate the complaint of no water and the handpiece getting hot.Check your inserts for any damage or clogging.Make sure only 30k denstply sirona inserts are being used with this unit, any other brand can cause issues.Handpiece 01/2023, hdpc 12/2022.Within warranty? no.
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Search Alerts/Recalls
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