BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1062382 · Received May 30, 2008

    Report

    Report Number
    1062382
    Event Type
    Malfunction
    Date Received
    May 30, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 29, 2008
    Manufacturer
    KARL STORZ LITHOTRIPSY-AMERICA, INC.
    Product Code
    FFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FAULTY EQUIPMENT AND MISSING PART RIGID. UNAVAILABILITY OF URETEROSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * LITHOTRIPTER SYSTEM FFL KARL STORZ LITHOTRIPSY-AMERICA, INC. 27080 *

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR