BEUDAMED
    FDA Adverse Event Summary report: N

    MEDILAS H

    MDR report key: 1232643 · Received November 12, 2008

    Report

    Report Number
    1232643
    Date Received
    November 12, 2008
    Date of Event
    November 11, 2008
    Report Date
    November 12, 2008
    Manufacturer
    DORNIER MED TECH AMERICA, INC.
    Product Code
    GEX
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CYSTOSCOPY LEFT URETEROSCOPY LASER LITHOTRIPSY URETERAL STENT PLACEMENT LEFT RETROGRADE PYELOGRAM-HOLMIUM LASER. LASER NOT WORKING PROPERLY-ONLY ABLE TO COMPLETE CYSTOSCOPY. STENT PLACED AND STONE WAS RELEASED. THEREFORE, NO HARM TO PT AND PT DOES NOT NEED TO RETURN FOR ANOTHER PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDILAS H LASER, HOLMIUM GEX DORNIER MED TECH AMERICA, INC. MEDILAS H *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR