BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONMED

    MDR report key: 1253343 · Received November 26, 2008

    Report

    Report Number
    1720159-2008-00036
    Event Type
    Injury
    Date Received
    November 26, 2008
    Report Date
    November 3, 2008
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    PMA / PMN Number
    K020186
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    AFTER SURGERY, THE O.R. NURSE WAS REMOVING HANDPIECE AND PATIENT PAD FROM THE SYSTEM 5000 WHEN SHE RECEIVED A SHOCK. DURING SURGERY, THE O.R. TEAM STATED THEY WERE HAVING TROUBLE WITH THE ROCKER SWITCH ON THE HANDPIECE. AFTER TURNING EVERYTHING OFF AND BACK ON, THEY WERE ABLE TO PROCEED WITH THE CASE, NO ONE CAN CONFIRM IF THE HANDPIECE WAS CHANGED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED ELECTROSURGICAL GENERATOR GEI CONMED ELECTROSURGERY SYSTEM 5000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other