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Catalog Number 8184001 |
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 plus g136 they allege that insert gets very hot.No injury was reported from the alleged event.
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Manufacturer Narrative
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Notes: (b)(6) 24 repair tech: jcb e1z probe, inner module, hp shorted recessed pin in handpiece.Dead batteries clogged water filter restricting water flow.Ran unit for 1 hour without any problem.Replaced damaged/worn components and recalibrated unit to factory specs.
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Search Alerts/Recalls
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