BEUDAMED
    FDA Adverse Event Summary report: N

    EXCALIBUR PLUS

    MDR report key: 2123870 · Received June 3, 2011

    Report

    Report Number
    2123870
    Date Received
    June 3, 2011
    Date of Event
    February 3, 2011
    Report Date
    May 17, 2011
    Manufacturer
    CONMED CORP
    Product Code
    GEI
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE SURGICAL PROCEDURE, THE ESU ELECTROSURGICAL UNIT WAS IN USE. AN ACTIVE ELECTRODE CABLE WAS CONNECTED TO A CABLE ADAPTER THAT WAS PLUGGED INTO THE ESU. DURING THE PROCEDURE, SMOKE WAS NOTED AND DETERMINED TO BE EMANATING FROM THE CABLE ADAPTER. THE SURGICAL PROCEDURE WAS STOPPED AND ANOTHER ESU, CABLE ADAPTER AND ACTIVE ELECTRODE WERE OBTAINED TO CONTINUE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCALIBUR PLUS ELECTROSURGICAL GENERATOR GEI CONMED CORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR