BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONMED CORPORATION

    MDR report key: 454320 · Received April 15, 2003

    Report

    Report Number
    1720159-2003-00030
    Event Type
    Other
    Date Received
    April 15, 2003
    Date of Event
    February 27, 2003
    Report Date
    March 19, 2003
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OPEN HEART SURGERY. PT ON STAINLESS STEEL TABLE WITH A GEL PAD IN BETWEEN. GROUNDING PADS ON BILATERAL BUTTUCKS. PROCEDURE WAS 5-6 HOURS. DURING PROCEDURE ONE DOCTOR WAS HARVESTING VEINS AND ANOTHER DOING THE OPEN HEART SURGERY. SOMEONE COMMENTED THAT THERE WAS SMOKE/STEAM COMING FROM THE PT. AFTER THE PROCEDURE WHEN THE DRAPE WAS REMOVED THEY FOUND A DEEP BURN IN THE GROIN AREA IN THE SHAPE OF THE HANDLE OF A METAL CLIP THAT WAS USED ON THE DRAPE IN THAT AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED CORPORATION ELECTROSURGICAL UNIT GEI CONMED ELECTROSURGERY EXCALIBUR PLUS PC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other SUREFIT DISPERSIVE ELECTRODE.| VALLEYLAB PENCIL,