BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 2613782 · Received May 19, 2009

    Report

    Report Number
    1221826-2009-00015
    Event Type
    Other
    Date Received
    May 19, 2009
    Date of Event
    April 20, 2009
    Report Date
    May 18, 2009
    Manufacturer
    KARL STORZ ENDOVISION
    Product Code
    FFS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AT THE CONCLUSION OF A SPINAL PROCEDURE, IT IS ALLEGED THAT OPERATING ROOM PERSONNEL NOTICED THAT THE LIGHT CABLE HAD A BROWN BURN MARK ON THE SHEATHING NEAR STRAIN RELIEF. THEY CHECKED THE AREA THE CABLE WAS RESTING ON AND FOUND A HOLE IN THE DRAPE AND A MINOR BURN ON THE PT'S LEFT BUTTOCK MEASURING 5MM BY 5MM. THEY ICED IT AND PUT A DRESSING ON; NO FURTHER MEDICAL TREATMENT WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ LIGHT CABLE FFS KARL STORZ ENDOVISION 495NA KH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other