Catalog Number A100400000000 |
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 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.Additional information regarding the patient outcome has been requested and will be submitted as it becomes available.
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Event Description
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It was reported that a x-smart contra angle will not hold files.The event outcome is unknown as of this mdr evaluation.
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Event Description
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Additional information received indicating that no injury resulted.
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Manufacturer Narrative
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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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Manufacturer Narrative
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Multiple unsuccessful attempts were made to obtain the device for evaluation.
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Search Alerts/Recalls
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