Catalog Number A100400000000 |
Device Problems
Computer Operating System Problem (2898); 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 contra angle won't hold files; no injury resulted.
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Manufacturer Narrative
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X-smart head cap.Bad maintenance (user).Pcb has a problem and can not deal anymore with battery and micromotor (shows error e-2 when handpiece is activated and works intermittently).X-smart cartridge.Various mechanical problem.It was not tested because the heater set is broken.X-smart neck.Various mechanical problem.It doesn't have any value because when we started the unit we can see on the screen ready for download, so than it missing the program.It's probably caused by a bad functioning of the microcontroller on the pcb card.Note: the covid-19 pandemic caused a disruption in normal business activities, resulting in late submission of this report.
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Search Alerts/Recalls
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