BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KARL STORZ ENDOSCOPY AMERICA INC

    MDR report key: 458769 · Received May 8, 2003

    Report

    Report Number
    MW1028382
    Event Type
    Injury
    Date Received
    May 8, 2003
    Date of Event
    May 5, 2003
    Report Date
    May 6, 2003
    Manufacturer
    KARL STORZ ENDOSCOPY AMERICA, INC.
    Product Code
    FFK
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PT WAS UNDERGOING A CYSTOSCOPY, "LITHOAPAXY" WITH THE LITHORITE INSTRUMENT. THE INSTRUMENT BROKE AND WAS FOUND IN THE PENILE MEATUS. ENTIRE INSTRUMENT BROKE PLUS BROKEN PIECE WAS REMOVED BY THE SURGEON RESULTING IN UNDUE TRAUMA TO THE MEATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ ENDOSCOPY AMERICA INC LITHORITE FFK KARL STORZ ENDOSCOPY AMERICA, INC. 27074B *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization