BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KARL STORZ LAPAROSCOPE

    MDR report key: 1870634 · Received October 7, 2010

    Report

    Report Number
    MW5017717
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 7, 2010
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FAILURE OF LAPAROSCOPIC EQUIPMENT DURING RECOVERY OF LIVING DONOR KIDNEY. MONITOR IMAGES VERY BLURRY AND YELLOW STREAKS RUNNING DOWN SCREEN AND FREQUENT COMPLETE FAILURE. EQUIPMENT TOOK AN ESTIMATED 45 MINUTES TO REPAIR, DURING WHICH TIME THE PATIENT WAS IN THE OPERATING ROOM AND INTUBATED/SEDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ LAPAROSCOPE LAPAROSCOPE/VIDEOSCOPE GCJ KARL STORZ ENDOSCOPY-AMERICA, INC. SC-SX 19-A1A11

    Patients

    Seq Age Sex Outcome Treatment
    1 Other