Catalog Number A103200000000 |
Device Problems
Device Slipped (1584); 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.
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Event Description
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In this event it is reported that an x-smart plus won't hold files.Further information requested.
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Manufacturer Narrative
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After inspection found the x-smart plus cartridge the rotation of the file is difficult because the ball bearing is damaged and x-smart plus head cap rusty.Replaced 1x xp contra-angle 6:1 a103300000000.
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Manufacturer Narrative
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Additional information has been received for this event.There was no patient injury that occurred.
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Search Alerts/Recalls
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