Catalog Number A100400000000 |
Device Problems
Defective Device (2588); Detachment of Device or Device Component (2907)
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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 won't hold files; no injury resulted.
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Manufacturer Narrative
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X-smart head cap; bad maintenance (user); there is some foreign matter on the head cap.X-smart cartridge; bad maintenance (user); i note that the cartridge is rusted.X-smart neck; various mechanical problem; foreign matter.Replaced 1 x x head cap h1004c5210500, 1 x x cartridge h1004c5210150 and 1 x x neck h1004c5470220.
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Search Alerts/Recalls
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