BEUDAMED
    FDA Adverse Event Other Summary report: N

    DISPOSABLE FALOPE-RING BAND APPLICATION KIT

    MDR report key: 1673200 · Received April 30, 2010

    Report

    Report Number
    2183680-2010-00019
    Event Type
    Other
    Date Received
    April 30, 2010
    Date of Event
    March 26, 2010
    Report Date
    April 30, 2010
    Manufacturer
    GYRUS MEDICAL, INC
    Product Code
    KNH
    PMA / PMN Number
    P870076
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE FALLOPIAN TUBES BEING TORN BY THE DEVICE COULD NOT BE CONFIRMED. THE INVESTIGATION RESULTS DID NOT PROVIDE OR SUGGEST A CAUSE FOR THE FALLOPIAN TUBES TO BE TORN. THE DEVICE FUNCTIONED AND OPERATED AS DESIGNED; PER THE DEVICE SIMULATION, IT MET THE INSPECTION CRITERIA AS CALLED OUT IN THE SPECIFICATIONS AND IFU. A REVIEW OF THE DEVICE BUILD RECORDS ASSOCIATED WITH THIS LOT DID NOT SHOW ANY DISCREPANCIES WITH THE MANUFACTURE OF THE LOT.

    Description of Event or Problem · 1

    WHILE THE SURGEON WAS PERFORMING A TUBAL LIGATION PROCEDURE, THE LEFT FALLOPIAN TUBE WAS SEVERED WHILE CAPTURING/BANDING. THE RIGHT FALLOPIAN TUBE WAS TRANSECTED WHILE CAPTURING/BANDING. BOTH TUBES WERE CAUTERIZED TO ACHIEVE HEMOSTASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE FALOPE-RING BAND APPLICATION KIT DISPOSABLE FALOPE-RING BAND APPL. KIT KNH GYRUS MEDICAL, INC 006889-901 145670AC

    Patients

    Seq Age Sex Outcome Treatment
    1