BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ULTRA

    MDR report key: 3466284 · Received November 6, 2013

    Report

    Report Number
    MW5032653
    Event Type
    Injury
    Date Received
    November 6, 2013
    Date of Event
    October 21, 2013
    Report Date
    November 5, 2013
    Manufacturer
    COVIDIEN SURGICAL
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    COVIDIEN STAPLER WHEN FIRED ACROSS A VESSEL THAT IS SUPPOSE TO LAY STAPLE LINES AND CUT BETWEEN THE TWO DID NOT EITHER LAY THE STAPLES OR CLOSE CORRECTLY, RESULTING IN BLEEDING. SURGEONS USED OTHER MEASURES TO CONTROL BLEEDING, LIG-A-CLIP, SUTURE, DURA SEAL AND FLOSEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571412 ENDO GIA ULTRA STAPLER GDW COVIDIEN SURGICAL B3A0126LX
    571413 RELOADER STAPLER GDW COVIDIEN SURGICAL N3D0744LX

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention