BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1212243 · Received October 26, 2008

    Report

    Report Number
    1212243
    Event Type
    Malfunction
    Date Received
    October 26, 2008
    Date of Event
    August 15, 2008
    Report Date
    October 26, 2008
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Product Code
    GCT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THERE ARE DIFFERENT LIGHT CORDS FOR ENDOSCOPIC CASES. THE TIPS OF THE LIGHT CORDS CAN PROJECT PAST THE SHEATH THAT SCREWS INTO THE SCOPES. WHEN THE SCOPE IS DISCONNECTED, IT IS HUMAN NATURE TO SET THE CORD DOWN FOR A SHORT WHILE. THIS IS NOT GOOD IN GENERAL, BUT WHEN THE TIP IS NOT PROTECTED, IT CAN CAUSE A BURN TO WHATEVER IT TOUCHES (IT MAY BE 500+ DEGREES), USUALLY THE DRAPES. IF THERE WAS OXYGEN NEARBY, THERE IS POTENTIAL FOR A FIRE. THIS HAS HAPPENED ON MULTIPLE OCCASIONS. WE HAVE ASKED TO HAVE ALL OF THESE LIGHT CORDS REMOVED. I UNDERSTAND THAT SOME SURGEONS PREFER THESE CORDS, SO THEY ARE USED OCCASIONALLY. HENCE, THE FIRE TODAY. THE BLUE DRAPE AND THE PATIENTS BLANKET HAD A HOLE/BURN ON THEM. IF THE PATIENT WAS CLOSER, THE PATIENTS SKIN WOULD HAVE BEEN BURNED AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * CORD, FIBER OPTIC LIGHT GCT KARL STORZ ENDOSCOPY-AMERICA, INC. 495ND NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR