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Catalog Number 8187501 |
Device Problem
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 jet plus g137 they allege that the water, handpiece and insert tip gets hot.No injury was reported from the alleged event.
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Manufacturer Narrative
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05/07/24 cn.Hpc# 12210 sterimate# 202112-0 a2e reg, needle valve, hp flow control clogged no powder flow due to a blockade in the hp.Deteriorated nozzle grip.Debris build up in the water filter.Dead/low batteries in wireless foot pedal.Cleaned up the blockade, tested and recalibrated to manufacturing specifications.Qa by jb.
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Search Alerts/Recalls
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