BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE

    MDR report key: 4131327 · Received September 17, 2014

    Report

    Report Number
    4131327
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    September 14, 2014
    Report Date
    September 17, 2014
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US

    Narratives

    Description of Event or Problem · 1

    STAPLER DIDN'T FIRE ALL THE WAY THROUGH, THEN SEEMED TO GET STUCK COMING BACK.....ENTERO-ILEOSTOMY WAS TESTED FOR LEAKS WITH AIR, SALINE, AND METHELYNE BLUE TREATED SALINE AND OVER-SEWN WITH 2-0 SILK SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575513 PROXIMATE STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY * K4DV6L

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR