Catalog Number A100400000000 |
Device Problems
Device Operates Differently Than Expected (2913); Unintended Movement (3026)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
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 some rust on the head cap and the cartridge is rusted, both are due to improper maintenance by the user.Inside of the handpiece casing is broken.Also, the rotation is not fluid in the neck.
|
|
Search Alerts/Recalls
|