BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 1548198 · Received November 20, 2009

    Report

    Report Number
    1221826-2009-00038
    Event Type
    Other
    Date Received
    November 20, 2009
    Date of Event
    October 9, 2009
    Report Date
    November 18, 2009
    Manufacturer
    KARL STORZ ENDOVISION
    Product Code
    FFS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORT OF MALFUNCTION OF CABLE; (B)(4) CHECKED CABLE AFTER PROCEDURE AND FOUND NO PROBLEM; HE RELEASED IT BACK INTO CIRCULATION.

    Description of Event or Problem · 1

    DOCTOR WAS PERFORMING A STONE FRAGMENTATION AND REMOVAL PROCEDURE WHEN THE ACTIVE LIGHT CABLE WAS DRAPED OVER THE PT DURING A SCOPE EXCHANGE. THEY USUALLY DRAPE IT OVER THE PT SO THE ACTIVE END IS HANGING DOWN OFF THE TABLE. IN THIS INSTANCE, THE LIGHT CABLE SLIPPED BACK UP AND MADE CONTACT WITH THE PT. AFTER THE PROCEDURE WAS COMPLETED, THEY DISCOVERED THAT THE PT HAD RECEIVED A BURN ON THE BACK OF THE KNEE AREA ABOUT THE SIZE OF A DIME. SURGEON DETERMINED THAT IT WAS MINOR AND APPLIED SILVADENE CREAM. THEY HAVE SINCE SEEN THE PT AND HER CONDITION IS GOOD; BURN IS HEALING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other