Catalog Number A100400000000 |
Device Problems
Detachment of Device or Device Component (2907); Mechanics Altered (2984); Physical Resistance/Sticking (4012)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/02/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
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 results are not available as of this report.Evaluation results will be submitted as they become available.
|
|
Event Description
|
In this event it is reported that x-smart w/contra angle eur did not rotate, did resist during rotation and file was not able to move.There was no injury to patient.
|
|
Manufacturer Narrative
|
After inspection -found cartridge blocked.Cartridge and head cap replaced.
|
|
Search Alerts/Recalls
|