Catalog Number V041185000502 |
Device Problem
Mechanical Problem (1384)
|
Patient Problem
Device Embedded In Tissue or Plaque (3165)
|
Event Type
malfunction
|
Event Description
|
In this event it is reported that a vdw.Connect drive handpiece without ca was involved in 3 file breakages at 3 different patients.This is 1 of 3 reports.The broken parts still remain in the root canal of the patient.
|
|
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 21 cfr part 803.
|
|
Manufacturer Narrative
|
2 (two) unsuccessful request for product return have been made and documented.Complaint will be reopened as soon as suspect product arrives per 8000-sop-038 [1].All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.
|
|
Search Alerts/Recalls
|