Catalog Number A100400000000 |
Device Problems
Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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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 an 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).The file is hard to remove, this failure is probably caused by rust or other foreign matter in the head cap.X-smart neck: rotation not fluid.X-smart cartridge: rotation not fluid.
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Search Alerts/Recalls
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