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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 results are not available 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 an eddy irrigation tip broke during treatment.All broken pieces were retrieved and no injury resulted.
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Manufacturer Narrative
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No smooth breakages; melted; breakages due to thermal influences.Misuse.Tip 1: broken at 28 mm point of passive part, active part measuring approx.28 mm.Tip cavi 2.Tip 2: broken approx.At 25 mm point at passive part and at 22 mm point of active part.Part in between is missing.No further broken parts received.Tip cavi 4.
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Search Alerts/Recalls
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