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 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-smartcontra angle did not hold files.The event outcome is unknown as of this mdr evaluation.
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Manufacturer Narrative
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Additional information has been received indicating that no injury resulted.X-smart cartridge: various mechanical problem.I note that the cartridge is blocked.Replaced by 1x x cartridge h1004c5210150, 1x x head cap h1004c5210500, 1x x neck h1004c5470220.
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Search Alerts/Recalls
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