BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARGON BEAM COAGULATOR

    MDR report key: 2171511 · Received July 15, 2011

    Report

    Report Number
    2171511
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 15, 2011
    Manufacturer
    CONMED
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    ARGON BEAM DEVICE TIP BROKE DURING LIVER TRANSPLANT SURGERY. LONG NEEDLE TIP CAME OUT OF ARGON TIP. ALL BROKEN PIECES WERE RETRIEVED DURING SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARGON BEAM COAGULATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONMED 6500 *
    2 ARGON DISPOSABLE TIP ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONMED * *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR