Catalog Number A100400000000 |
Device Problems
Detachment of Device or Device Component (2907); Therapeutic or Diagnostic Output Failure (3023)
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Patient Problems
No Consequences Or Impact To Patient (2199); 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).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.I note that the cartrigde is blocked.X-smart neck: various mechanical problem.Ball bearing of the neck is defective.It is not possible to be determined the root cause with certainty.The root cause is either a mechanical problem or a bad maintenance of user.
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Search Alerts/Recalls
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