BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FBK DUAL INC. W/O TROCAR 8/PK

    MDR report key: 5610390 · Received April 26, 2016

    Report

    Report Number
    2951238-2016-00386
    Event Type
    Injury
    Date Received
    April 26, 2016
    Date of Event
    April 1, 2016
    Report Date
    May 25, 2016
    Manufacturer
    GYRUS AMCI, INC.
    Product Code
    KNH
    PMA / PMN Number
    PP870076
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORT OF THE DEVICE NOT DEPLOYING THE FALLOPIAN RING COULD NOT BE CONFIRMED. VISUAL INSPECTION FOUND THERE WAS ONE RING BAND STILL ON THE TIP OF THE APPLICATOR. TWO BANDS WERE LOADED AND DEPLOYED AS EXPECTED. THERE WERE NO SIGNIFICANT ABNORMALITIES OBSERVED DURING DEVICE FUNCTIONALITY TESTING. NO SHARP EDGES OR NICKS WERE PRESENT. THE HANDLE WAS ALSO DISASSEMBLED TO REVEAL THE TRIGGER TUBE IN GOOD CONDITION WITH ONLY A SLIGHT WEAR MARK ON ONE SIDE.

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE CAUSE OF THE REPORTED FAILURE CANNOT BE DETERMINED. THE MOST LIKELY CAUSE OF THE DAMAGE CAN BE ATTRIBUTED TO INADVERTENT HANDLING OF THE DEVICE. THE INSTRUCTION MANUAL CONTAINS WARNING STATEMENTS IN AN EFFORT TO PREVENT POSSIBLE DAMAGE. "THE FALOPE-RING BAND MAY BE DAMAGED AND/OR BREAK DURING LOADING WITH THE USE OF DAMAGED OR REUSED LOADING DEVICES. USING STANDARD STERILE TECHNIQUE, LOAD THE FALOPE-RING BAND AS FOLLOWS (DO NOT LOAD THE BANDS MORE THAN 30 MINUTES PRIOR TO PLACEMENT). ALWAYS GRASP THE FALLOPIAN TUBE WITH THE SHORTER INFERIOR TONG POSITIONED ON THE BOTTOM TO AVOID INJURY TO THE TUBE."

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A BILATERAL TUBAL LIGATION PROCEDURE, THE DEVICE WOULDN'T DEPLOY THE FALLOPIAN RING. IN AN ATTEMPT TO RELEASE THE FALLOPIAN RING AND CUT THE FALLOPIAN TUBE, THE FALLOPIAN TUBE WAS SEVERED. THE DEVICE WAS REMOVED AND A NON-OLYMPUS DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL BLEEDING WAS OBSERVED AND NO OTHER SURGICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264672 FBK DUAL INC. W/O TROCAR 8/PK FALOPE-RING BAND APPLICATION KNH GYRUS AMCI, INC. 006889-901 MK984367

    Patients

    Seq Age Sex Outcome Treatment
    1 Other