BEUDAMED
    FDA Adverse Event Other Summary report: N

    FLEXIBLE URETEROPYELOSCOPE KIT

    MDR report key: 2243443 · Received July 1, 2011

    Report

    Report Number
    1218764-2011-00004
    Event Type
    Other
    Date Received
    July 1, 2011
    Date of Event
    April 11, 2011
    Report Date
    July 1, 2011
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    FGB
    PMA / PMN Number
    K012925
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFO FROM THE HOSP HAVE BEEN UNSUCCESSFUL, AND 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

    WHILE FINISHING A URETEROSCOPY PROCEDURE, THE SURGEON NOTICED SOMETHING IN THE PT'S URETER THAT HAD NOT BEEN THERE PREVIOUSLY ON FLUORO. HE THEN WENT IN WITH A GRASPER AND WAS ABLE TO RETRIEVE THE FOREIGN BODY WHICH APPEARED TO BE A SMALL PIECE OF BLACK COATING FROM THE END OF THE URETEROSCOPE. THE PT WAS CHECKED UNDER FLUORO AND NOTHING ELSE WAS VISIBLE. PT WAS RELEASED W/O HARM OR ADDITIONAL STAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIBLE URETEROPYELOSCOPE KIT FLEXIBLE URETEROPYELOSCOPE KIT FGB GYRUS ACMI, INC. DUR-8

    Patients

    Seq Age Sex Outcome Treatment
    1