Catalog Number 95-D-5 |
Device Problem
Break (1069)
|
Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
There has been a previous report received 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 is reported that a excavator double ended usa 5 broke during use.Outcome of this event is unknown as of this mdr.Further information requested.
|
|
Manufacturer Narrative
|
Additional fda coding being added after investigation of device.Adding additional type of investigation code 10.This is a follow up report to add this additional code.Investigation update: device returned for investigation.Results: summary: the two returned excavators double ended usa 5 have each one broken active part.Breakages occurred at the base of the pallets.No material defect was found during analysis of the rupture patterns.Second active parts are not damaged.Nothing unusual to report was found during dhr review (batch #1749719).Root causes are not identified.We will track this kind of event and monitor the trend.This is to correct and remove the codes that were initially reported - removing codes for: type of investigation code - 4114.Removing code due to receiving device for inspection/investigation.
|
|
Manufacturer Narrative
|
Summary: involved product that broke during use was not returned and cannot be analyzed.Nothing unusual to report was found during dhr review (batch #1749719).Root causes are not identified.We will track this kind of event and monitor the trend.
|
|
Search Alerts/Recalls
|