Catalog Number A100400000000 |
Device Problems
Defective Device (2588); Detachment of Device or Device Component (2907)
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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 plus contra angle won't hold files; no injury resulted.
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Manufacturer Narrative
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X-smart plus drive shaft: bad maintenance (user) there is some foreign matter on the drive shaft.X-smart plus cartridge: various mechanical problem the ball bearing of the cartridge is broken.(the balls are more in the ball bearing) x-smart plus head cap: bad maintenance (user) there is some foreign matter on the head cap.
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Search Alerts/Recalls
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