BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIRCON

    MDR report key: 520328 · Received March 19, 2004

    Report

    Report Number
    MW1031615
    Event Type
    Malfunction
    Date Received
    March 19, 2004
    Date of Event
    March 18, 2004
    Report Date
    March 19, 2004
    Manufacturer
    CIRCON CORP
    Product Code
    EYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CYSTOSCOPY WITH MICROVASIVE DOUBLE LUMEN 10F CATHETER WITH GUIDEWIRE PASSED INTO LT URETERAL ORIFICE. PASSED UP TO STONE, UNABLE TO PASS WIRE. CATHETER PASSED UP TO STONE, COULD NOT PASS WITH PRESSURE RETROGRADE. STONE NOT DISLODGED. PROCEDURE COMPLETE, CATHETER REMOVED. CATHETER APPEARED TO HAVE DISTAL END CRUSHED AND TIP BROKE OFF IN PT URETER. FLUOROSCOPY DID NOT SHOW-FOREIGN BODIES IN URETER OR BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIRCON 10 FR DUAL LUMEN CATHETER EYB CIRCON CORP REF 608 857451K

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other