BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 2596777 · Received December 24, 2010

    Report

    Report Number
    2954921-2010-00042
    Event Type
    Other
    Date Received
    December 24, 2010
    Date of Event
    September 30, 2010
    Report Date
    December 22, 2010
    Manufacturer
    NDS SURGICAL IMAGING
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    WE FIRST BECAME AWARE OF THIS INCIDENT WHEN WE RECEIVED MAUDE EVENT REPORT #(B)(4) ON (B)(4) 2010. CUSTOMER HAS REPLACED THIS AGED MONITOR WITH A NEW HD MONITOR AND WILL RETURN THE OLD MONITOR FOR EVALUATION.

    Description of Event or Problem · 1

    ALLEGEDLY, DURING A LAPAROSCOPIC RECOVERY OF LIVING DONOR KIDNEY PROCEDURE, THE MONITOR IMAGES WERE VERY BLURRY AND HAD YELLOW STREAKS RUNNING DOWN THE SCREEN. CUSTOMER ATTEMPTED TO FIX THE MONITOR, DURING WHICH TIME THE PT WAS IN THE OPERATING ROOM AND THE PROCEDURE WAS DELAYED FOR AN ADDITIONAL 45 MINS. MONITOR WAS EVENTUALLY SWAPPED OUT AND THE PROCEDURE WAS COMPLETED WITH NO IMPACT ON PT. PT CONDITION POST-OP WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ 19" FLAT PANEL MONITOR GCJ NDS SURGICAL IMAGING 9319NR-A24

    Patients

    Seq Age Sex Outcome Treatment
    1 Other