Catalog Number A066100000100 |
Device Problem
Break (1069)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Event Description
|
In this event it is reported that start-x tip ems insert 1 tip broke during use.The broken parts have been retrieved from the patient's mouth; no injury resulted.
|
|
Manufacturer Narrative
|
While no serious injury resulted in this event, 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 was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.
|
|
Manufacturer Narrative
|
Summary: involved product that broke during use was not returned and cannot be analyzed.Moreover, no unused insert is available for evaluation.Nothing unusual to report was found during dhr review (batch #1814213).Information given regarding technique is only partial, we cannot rule on its compliance with maillefer's recommendations.Root causes are not identified.We will track this kind of event and monitor the trend.
|
|
Search Alerts/Recalls
|