Catalog Number A100400000000 |
Device Problems
Detachment of Device or Device Component (2907); Output Problem (3005)
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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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There has been a previous report received with a similar device where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event 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 it was reported that a x-smart contra angle did not hold files; no injury resulted.
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Manufacturer Narrative
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X-smart head cap bad maintenance (user) the file is hard to remove, this failure is probably caused by rust or other foreign matter in the head cap.X-smart cartridge various mechanical problem the file does not fit on the contra angle because hook of cartridge is broken.X-smart neck other rotation not fluid.Replaced 1 x x cartridge h1004c5210150, 1 x x neck h1004c5470220 and 1 x x head cap h1004c5210500.
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Search Alerts/Recalls
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