BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FALOPE-RING BAND TWO-RING APPLICATOR

    MDR report key: 2180636 · Received May 5, 2011

    Report

    Report Number
    2183680-2011-00011
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 4, 2011
    Report Date
    May 5, 2011
    Manufacturer
    GYRUS MEDICAL INC.
    Product Code
    KNH
    PMA / PMN Number
    P870076
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS CURRENTLY STILL UNDER INVESTIGATION AND TESTING AT OUR FACILITY. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. WHEN FURTHER INFO BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    DURING A PROCEDURE WHILE USING THE FALOPE-RING BAND TWO-RING APPLICATOR, THE FALLOPIAN TUBES WERE LACERATED, THE SURGEON TRIED ANOTHER LIKE DEVICE AND THE SAME THING HAPPENED. (SEE MFR. # 2183680-2011-00010). THE SURGEON THINKS THE LACERATION HAPPENED PARTLY BECAUSE OF THE PATIENT'S ANATOMY BEING EXCESSIVE EDEMA, THE TISSUE WAS VERY FRIABLE. THE SURGEON USED A KLEPPINGER DEVICE TO FINISH THE PROCEDURE. THERE WAS NO LONGER STAY FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FALOPE-RING BAND TWO-RING APPLICATOR FALOPE-RING BAND TWO-RING APPLICATOR KNH GYRUS MEDICAL INC. 000940-501

    Patients

    Seq Age Sex Outcome Treatment
    1