Catalog Number A100400000000 |
Device Problems
Detachment of Device or Device Component (2907); Output Problem (3005)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/20/2022 |
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 results are not available 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 an x-smart contra angle won't hold files; no injury resulted.
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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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Manufacturer Narrative
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Device was received and inspected.The investigation results for this complaint are: found that rotation not fluid.1x x-smart cartridge, 1x x-smart casing assembly, 1x x-smart head cap and 1x x-smart motor assembly replaced.
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Search Alerts/Recalls
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