BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURESTRAP

    MDR report key: 5385052 · Received January 22, 2016

    Report

    Report Number
    5385052
    Event Type
    Malfunction
    Date Received
    January 22, 2016
    Date of Event
    November 17, 2015
    Report Date
    November 30, 2015
    Manufacturer
    ETHICON, INC.
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING LAPAROSCOPIC REPAIR OF INCARCERATED UMBILICAL HERNIA. A 8 CM CIRCULAR ATRIUM C-QUR MESH WAS PLACED WITHIN THE PERITONEAL CAVITY. THE TAILS OF THE MESH WERE BROUGHT UP THROUGH THE MIDDLE OF THE FASCIAL DEFECT. THE FASCIA WAS THEN CLOSED USING #1 PDS SUTURE IN AN INTERRUPTED FASHION. ADEQUATE CLOSURE OF THE FASCIAL DEFECT WAS OBTAINED. THE TAILS OF THE MESH WERE THEN SECURED TO THE FASCIA USING 0 VICRYL SUTURE IN INTERRUPTED FASHION. THE PERINEAL CAVITY WAS THEN REINSUFFLATED WITH AIR. THE LAPAROSCOPE WAS INSERTED INTO THE PERINEAL CAVITY. THE MESH WAS SEEN TO BE ADJACENT TO THE ANTERIOR ABDOMINAL WALL. ATTEMPTS WERE MADE TO SECURE THE MESH TO THE ANTERIOR ABDOMINAL WALL USING A SECURE STRAP DEVICE. THE TACKER WAS UNABLE TO BE ADEQUATELY DEPLOYED INTO THE MESH. THREE ATTEMPTS WERE MADE. INSTEAD THE MESH WAS SUTURED IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43546 SECURESTRAP STAPLE, IMPLANTABLE, TACKER GDW ETHICON, INC. STRAP25 JJK449

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR MESH WAS BEING PLACED AGAINST ANTERIOR ABDOMINAL W