BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 981402 · Received November 21, 2007

    Report

    Report Number
    2020550-2007-00029
    Event Type
    Other
    Date Received
    November 21, 2007
    Date of Event
    October 24, 2007
    Report Date
    November 20, 2007
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    FFK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER THE DOCTOR USED LASER TO FRAGMENT STONES, HE TRIED 3 SCOPES AND HAD VISUALIZATION PROBLEMS AT BEGINNING OF RETRIEVAL. HE DECIDED TO CHANGE TO AN OPEN PROCEDURE TO REMOVE LARGE FRAGMENTS. AT THAT TIME, HE TRIED TO REMOVE THE 27076A AND FELT RESISTANCE; A FLUORSCOPE CONFIRMED THAT THE JAWS HAD BECOME MISALIGNED. HE WAS INSTRUCTED BY OUR TECH SUPPORT ON HOW TO REMOVE INSTRUMENT SAFELY, BUT SINCE HE WAS CHANGING TO AN OPEN PROCEDURE ANYWAY, HE DECIDED HE WOULD WAIT TO REMOVE INSTRUMENT THEN. ONCE IN THE OPEN PROCEDURE, HE AGAIN CALLED US FOR ASSISTANCE IN ALIGNING JAWS AND REMOVING INSTRUMENT; THIS WAS DONE SUCCESSFULLY WITH NO PT IMPACT. BLADDER STONE FRAGMENTS WERE RETRIEVED AND PROCEDURE COMPLETED. AFTER PROCEDURE, DR NOTICED SMALL HOLES IN BLADDER; HE DID NOT KNOW HOW THEY OCCURRED; HE CLOSED THEM AND ENDED PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ LITHOTRITE FFK KARL STORZ GMBH & CO. KG 27076A MN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other