BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STORTZ CUTTING LOOP

    MDR report key: 538903 · Received April 19, 2004

    Report

    Report Number
    538903
    Event Type
    Malfunction
    Date Received
    April 19, 2004
    Date of Event
    January 1, 2004
    Report Date
    February 1, 2004
    Manufacturer
    VANGUARD MEDICAL CONCEPTS, INC.
    Product Code
    FDC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING CYSTOSCOPIC TUR(TRANSURETHRAL ELECTRORESECTION) CASE WITH MICROVASIVE 24FR [FRENCH]. STORZ CUTTING LOOP WAS USED. AT END OF PROCEDURE AS DR. REMOVED THE SCOPE THE ELECTRODE SEPARATED INTO 3 PIECES - AN INNER CANNULA, OUTER CANNULA, AND TUBE OF INSULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STORTZ CUTTING LOOP CUTTING LOOP FOR RESECTOSCOPE FDC VANGUARD MEDICAL CONCEPTS, INC. 880-203 24FR. CUTTING LOOP STORZ SING VANGUARD LOT 389220

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other