BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOUBLE J CLOSED TIP URETERAL STENT, 24 CM, 6 FR

    MDR report key: 1360857 · Received January 29, 2009

    Report

    Report Number
    2183680-2009-00004
    Event Type
    Malfunction
    Date Received
    January 29, 2009
    Date of Event
    January 13, 2009
    Report Date
    January 29, 2009
    Manufacturer
    GYRUS MEDICAL INC.
    Product Code
    FAD
    PMA / PMN Number
    K781641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS BEING DISCARDED AND IS NOT BEING RETURNED FOR EVAL. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. WHEN FURTHER INFORMATION BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    A STENT WAS PUT IN PLACE IN 2008, DURING A RIGHT PARTIAL NEPHRECTOMY. THE FOLLOWING YEAR, THE PT CAME IN TO HAVE THE STENT REMOVED. DURING A ROUTINE FLUOROSCOPY, IT WAS DISCOVERED THAT THE STENT HAD BROKEN. THE SURGEON REMOVED ALL THE PARTS, AND THE STENT WAS DISCARDED. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOUBLE J CLOSED TIP URETERAL STENT, 24 CM, 6 FR DOUBLE J CLOSED TIP URETERAL STENT, 24 C FAD GYRUS MEDICAL INC. 5202800 MBGQ970

    Patients

    Seq Age Sex Outcome Treatment
    1