|
Catalog Number V041441000000 |
Device Problem
Break (1069)
|
Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
As a result of this malfunction, the potential for surgical intervention exists to preclude injury or illness that would necessitate medical or surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function.This event, therefore, is reportable per 21cfr part 803.This report is for the first device.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 a customer reported three eddy irrigation tip breakages during treatment with one patient.The outcome of the event is unknown as of this mdr evaluation.
|
|
Manufacturer Narrative
|
3 instruments broken - whole working part missing.1 working part broken at 28mmno smooth breakage, melted.Breakage due to thermal influence - misuse.Test of unused products passed the safety and mechanical test.No fault found on unused instruments.Nothing unusual to report was found during dhr review.Additional information was received indicating that the broken portion of the device was removed from the patient's tooth.
|
|
Search Alerts/Recalls
|
|
|