BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-Z GLIDER STRAIGHT TIP GW BX/5

    MDR report key: 1365178 · Received March 6, 2009

    Report

    Report Number
    2183680-2009-00012
    Event Type
    Malfunction
    Date Received
    March 6, 2009
    Date of Event
    February 16, 2009
    Report Date
    March 6, 2009
    Manufacturer
    GYRUS MEDICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED FOR EVAL. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFO BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    INCIDENT WAS REPORTED WITH OUR DUR-D, ACCESS SHEATH AND 35BX GUIDEWIRE. THE SURGEON WAS USING THIS EQUIPMENT AND PERFORATED A PT'S URETER. THE PT WAS 91 YRS OLD AND SUSPECTED OF HAVING CANCER IN THE KIDNEY. AS A RESULT OF THE PERFORATION, THE SURGEON HAD TO OPEN THE PT TO REPAIR THE URETER. ONCE HE OPENED, HE DISCOVERED THE PT HAD SEVERE CANCER AND REMOVED HIS KIDNEY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E-Z GLIDER STRAIGHT TIP GW BX/5 E-Z GLIDER STRAIGHT TIP GW BX/5 GEI GYRUS MEDICAL, INC. 35BX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention