BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KARL STORZ

    MDR report key: 812751 · Received January 11, 2007

    Report

    Report Number
    2020550-2007-00001
    Event Type
    Injury
    Date Received
    January 11, 2007
    Date of Event
    December 8, 2006
    Report Date
    January 10, 2007
    Manufacturer
    KARL STORZ ENDOVISION
    Product Code
    FFZ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DOCTOR WAS STARTING A LAP CHOLE PROCEDURE; THE LIGHT CABLE WAS PLUGGED INTO AN ACTIVE LIGHT SOURCE AND LAID ON THE PT DRAPE WITH NO SCOPE ATTACHED. A NURSE NOTICED SMOKE RISING FROM THE DRAPE. THEY MOVED LIGHT CABLE AND DRAPE AND FOUND THAT THE PT HAD REC'D A SMALL BURN ON THE CHIN APPROXIMATELY 4.8 MM IN SIZE. PATIENT WAS TREATED WITH SALINE, BACITRACIN OINTMENT AND A BANDAID WAS PUT ON. NO FURTHER TREATMENT WAS SCHEDULED OR PLANNED. HOSPITAL STATED THAT THERE WAS NO MALFUNCTION OF LIGHT CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ LIGHT CABLE FFZ KARL STORZ ENDOVISION 495NCS KF

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other| R