Catalog Number A100400000000 |
Device Problems
Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
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Patient Problem
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 where this malfunction has caused file separation.Since separation of a file could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur.As such, this event meets the criteria for reportability per 21 cfr 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 the handpiece of a x-smart rotated with resistance ; no injury resulted.
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Manufacturer Narrative
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X-smart head cap.Bad maintenance (user).The file is hard to remove, this failure is probably caused by rust or other foreign matter in the head cap.X-smart cartridge.Various mechanical problem.Rotation not fluid.Replaced 1 x x cartridge (b)(6) and 1 x x head cap (b)(6).
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Search Alerts/Recalls
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