Catalog Number A105100000000 |
Device Problems
Mechanical Problem (1384); Detachment of Device or Device Component (2907)
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Patient Problems
Insufficient Information (4580); 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 for 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 iq contra angle would not hold files.The event outcome is unknown as of this mdr evaluation.
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Manufacturer Narrative
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X-smart iq contra-angle.Bad maintenance (user).Too rusty, unrepairable.Additional information was received indicating that no injury resulted.
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Search Alerts/Recalls
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