Catalog Number A100400000000 |
Device Problems
No Device Output (1435); Detachment of Device or Device Component (2907)
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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 files stopped with torque of x-smart; no injury resulted.
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Manufacturer Narrative
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X-smart head cap: bad maintenance (user).There is some rust on the head cap.X-smart switch assembly: various electronic problem.The switch doesn't work , so it is not possible to turn on the micromor.X-smart cartridge: bad maintenance (user).I note that the cartridge is rusted.X-smart neck: other.Rotation not fluid.Replaced 1 x x switch assembly h1004e2810020, 1 x x neck h1004c5470220, 1 x x head cap h1004c5210500 and 1 x x cartridge h1004c5210150.
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Search Alerts/Recalls
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