Catalog Number A100400000000 |
Device Problems
Computer Operating System Problem (2898); Detachment of Device or Device Component (2907)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
In this event it was reported that a x-smart contra angle won't hold files; no injury resulted.
|
|
Manufacturer Narrative
|
X-smart head cap.Bad maintenance (user).It has to be changed with h 1004 u47 502 90.X-smart neck.Various mechanical problem.X-smart cartridge.Various mechanical problem.Need refresh.Note: the covid-19 pandemic caused a disruption in normal business activities, resulting in late submission of this report.
|
|
Search Alerts/Recalls
|