BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 3127755 · Received May 9, 2013

    Report

    Report Number
    2020550-2013-00020
    Event Type
    Other
    Date Received
    May 9, 2013
    Date of Event
    April 10, 2013
    Report Date
    May 9, 2013
    Manufacturer
    KARL STORZ ENDOSCOPY
    Product Code
    FFS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY, DURING A PROCEDURE, THE ACTIVE LIGHT CABLE WITH ADAPTOR BECAME SEPARATED FROM THE SCOPE AND FELL ONTO PT'S DRAPE; IT CREATED A BURN MARK ON THE DRAPE AND PT SUSTAINED A SMALL BURN ON RIGHT LOWER ABDOMEN. BURN WAS TREATED WITH ANTIBIOTIC OINTMENT. PT IS DOING FINE POSTOPERATIVE. REFERENCE TO MANUFACTURE REPORT # 1221826-2013-00020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205114 KARL STORZ LIGHT CABLE FFS KARL STORZ ENDOSCOPY 495NCS IF

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other