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Catalog Number V041441000000 |
Device Problem
Break (1069)
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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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As a result of this malfunction, the potential for surgical intervention exists to preclude injury or illness that would necessitate medical or surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function.This event, therefore, is reportable per 21cfr 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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In this event a customer reported that one eddy irrigation tip broke during treatment; no injury resulted.
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Manufacturer Narrative
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Working part is measuring approx.28,92 mm.Investigation done: no smooth breakage, breakage do to thermal influence.Misuse.
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Search Alerts/Recalls
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