BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FALOPE RING BAND APPLICATION KIT

    MDR report key: 2498043 · Received March 15, 2012

    Report

    Report Number
    2183680-2012-00018
    Event Type
    Malfunction
    Date Received
    March 15, 2012
    Date of Event
    February 9, 2012
    Report Date
    February 14, 2012
    Manufacturer
    GYRUS MEDICAL INC.
    Product Code
    KNH
    PMA / PMN Number
    P870076
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 INFORMATION BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TUBAL PROCEDURE THE DEVICE CUT THE PATIENTS FALOPE TUBE. THE SURGEON WAS ABLE TO USE BOVIE TO CAUTERIZE THE FALLOPIAN TUBE AFTER BEING CUT. NO OTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FALOPE RING BAND APPLICATION KIT FALOPE RING BAND APPLICATION KIT KNH GYRUS MEDICAL INC. 006889-901 369118JD

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization