Catalog Number A100400000000 |
Device Problems
Device Operates Differently Than Expected (2913); Unintended Movement (3026)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
There has been a previous report received 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.
|
|
Event Description
|
In this event it was reported that a xsmart suddenly goes into auto reverse mode; no injury resulted.
|
|
Manufacturer Narrative
|
Evaluation found the file is hard to remove, this failure is probably caused by rust or other foreign matter in the head cap.This is due to improper maintenance by the user.Also, the cartridge is blocked and the rotation is not fluid in the neck.
|
|
Search Alerts/Recalls
|