BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO ENDO5 ML

    MDR report key: 3252524 · Received July 24, 2013

    Report

    Report Number
    3003898360-2013-00323
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Date of Event
    May 23, 2013
    Report Date
    July 8, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE NOT RETURNED IN TIME FOR THIS REPORT. DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. COMPLAINT CANNOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION, THEREFORE, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THE DEFECT REPORTED AND A CORRECTIVE ACTION FOR IT. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: CLIPS WERE NOT RELEASING AFTER BEING FIRED. AS PER COMPLAINANT, "SURGEON USED ALTERNATE STRATEGIES TO ACHIEVE A PROPER SURGICAL OUTCOME." NO PT INJURY REPORTED. PT CURRENT CONDITION REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346230 AUTO ENDO5 ML CLIP APPLIER FZP TELEFLEX MEDICAL 01L1100024

    Patients

    Seq Age Sex Outcome Treatment
    1