BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 867654 · Received June 8, 2007

    Report

    Report Number
    2020550-2007-00015
    Event Type
    Other
    Date Received
    June 8, 2007
    Date of Event
    September 15, 2005
    Report Date
    June 7, 2007
    Manufacturer
    KARL STORZ ENDOVISION
    Product Code
    FGB
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    REGULATORY AFFAIRS RECEIVED A SUMMONS VIA CERTIFIED MAIL: DURING A URETEROSCOPY PROCEDURE, THE DR HAD DIFFICULTY REMOVING THE URETEROSCOPE. WHEN HE WAS ABLE TO, THE BLACK LINING/INSULATION CAME OFF THE DISTAL END OF THE URETEROSCOPE. THE PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE OF THE RIGHT KIDNEY TO SEARCH FOR THE LINING. AT THAT TIME, THEY FOUND A LACERATION OF THE PELVIS AND REPAIRED IT. THE PT WAS HOSPITALIZED FOR 8 DAYS. TWO DAYS AFTER DISCHARGE, THE PT WAS CHECKED INTO ER, AND A CAT SCAN REVEALED BILATERAL PULMONARY EMBOLI AND AN INTERIOR VENA CAVA FILTER WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ FLEXIBLE URETEROSCOPE FGB KARL STORZ ENDOVISION UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other