BEUDAMED
    FDA Adverse Event Other Summary report: N

    USA ELITE RIGID OPTICAL GRASPING FORCEPS

    MDR report key: 2223421 · Received August 10, 2011

    Report

    Report Number
    1519132-2011-00020
    Event Type
    Other
    Date Received
    August 10, 2011
    Date of Event
    September 11, 2009
    Report Date
    August 10, 2011
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFO FROM THE HOSPITAL HAVE BEEN UNSUCCESSFUL, AND THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. 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

    DURING A CYSTOLITHOLAPAXY AND LASER VAPORIZATION OF THE PROSTATE PROCEDURES, WHILE REMOVING BLADDER STONES WITH A COMBINATION OF STONE BREAKAGE AND STONE REMOVAL WITH THE GRASPING FORCEPS, THE TIP OF THE FORCEPS BROKE OFF INTO THE PT'S BLADDER. THE SURGEON WAS ABLE TO REMOVE THE BROKEN TIP. AN X-RAY OF THE KIDNEYS, URETERS AND BLADDER WAS TAKEN WITH NO REMAINING METAL SEEN. THE PROCEDURES WERE COMPLETED WITH NO COMPLICATIONS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 USA ELITE RIGID OPTICAL GRASPING FORCEPS USA ELITE RIGID OPTICAL GRASPING FORCEPS FCL GYRUS ACMI, INC. E8215

    Patients

    Seq Age Sex Outcome Treatment
    1