BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLD LIGHT FOUNTAIN POWER TL400

    MDR report key: 23276130 · Received October 14, 2025

    Report

    Report Number
    MW5177246
    Event Type
    Injury
    Date Received
    October 14, 2025
    Date of Event
    October 7, 2025
    Report Date
    October 9, 2025
    Manufacturer
    KARL STORZ ENDOSCOPY AMERICA INC.
    Product Code
    GCT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A PATIENT WAS UNDERGOING LAPAROSCOPIC SURGERY. AFTER THE PATIENT WAS PREPPED AND DRAPED, THE SURGICAL TEAM BEGAN SETTING UP EQUIPMENT. THE CAMERA, LIGHT, AND INSUFFLATION CORDS WERE CONNECTED TO THE STORZ TOWER. THE STERILE PORTION OF THE LIGHT CORD, ALONG WITH OTHER CORDS, WAS PLACED ON THE DRAPES OVER THE PATIENT. THE LIGHT SOURCE WAS SET TO MANUAL MODE AND WAS NOT ACTIVATED BY THE SURGICAL TEAM. THE STORZ TOWER SCREEN INDICATED THE LIGHT WAS IN "STANDBY" MODE. HOWEVER, THE ATTENDING SURGEON OBSERVED THAT THE LIGHT HAD AUTOMATICALLY TURNED ON, RESULTING IN TWO SMALL BURN HOLES IN THE DRAPE. THE CAMERA AND LIGHT CORD WERE IMMEDIATELY REMOVED FROM THE FIELD. THE PATIENT'S SKIN WAS ASSESSED AND FOUND TO BE UNHARMED. THE PATIENT WAS RE-PREPPED AND RE-DRAPED, AND NEW CAMERA AND LIGHT CORDS WERE OPENED AND USED FOR THE REMAINDER OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198885 COLD LIGHT FOUNTAIN POWER TL400 LIGHT SOURCE, ENDOSCOPE, XENON ARC GCT KARL STORZ ENDOSCOPY AMERICA INC. TL400

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown