BEUDAMED
    FDA Adverse Event Other Summary report: N

    FALOPE-RING BAND TWO-RING APPLICATOR, 8 MM

    MDR report key: 1833918 · Received September 9, 2010

    Report

    Report Number
    2183680-2010-00045
    Event Type
    Other
    Date Received
    September 9, 2010
    Date of Event
    August 16, 2010
    Report Date
    September 9, 2010
    Manufacturer
    GYRUS MEDICAL INC.
    Product Code
    KNH
    PMA / PMN Number
    P870076
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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

    WHILE PERFORMING A TUBAL LIGATION PROCEDURE, THE APPLICATOR OF THE DEVICE TORE THE FALLOPIAN TUBES WHEN APPLYING THE BANDS. THE BANDS BROKE DURING THE APPLICATION. ALL PIECES WERE RETRIEVED FROM THE PATIENT WITH NO PATIENT HARM. A HARMONIC SCALPEL WAS USED TO COMPLETE THE CASE SINCE THE TUBES WERE TORN ALREADY. THERE WAS NO INDICATION OF DISEASED TUBES AND THE PATIENT DID NOT REQUIRE PROLONGED HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FALOPE-RING BAND TWO-RING APPLICATOR, 8 MM FALOPE-RING BAND TWO-RING APPLICATOR KNH GYRUS MEDICAL INC. 000940-501 8031011

    Patients

    Seq Age Sex Outcome Treatment
    1