BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPOUCH

    MDR report key: 6120481 · Received November 22, 2016

    Report

    Report Number
    6120481
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    October 13, 2016
    Report Date
    October 26, 2016
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE EPIGASTRIC PORT WAS ENLARGED SLIGHTLY TO ACCOMMODATE THE ENDOPOUCH. UPON PULLING THE BAG WITH THE GALLBLADDER THROUGH, THE BOTTOM PART OF THE BAG FRAGMENTED AND CAME OUT. THE GALLBLADDER WAS THEN DELIVERED. IT WAS NOTED THAT THERE WAS A TINY PIECE OF THE PLASTIC ENDOPOUCH, WHICH HAD BROKEN OFF OF THE MAIN BAG. IT WAS THOUGHT INITIALLY THAT IT WAS VISUALIZED IN THE EPIGASTRIC TROCAR SITE. THOROUGH EXPLORATION OF THE SITE AND THE INTRAPERITONEAL CAVITY FOR A SMALL 2-3MM PIECE OF THE BAG WAS UNEVENTFUL. WE WERE UNABLE TO FIND THE PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771027 ENDOPOUCH LAPAROSCOPE, GENERAL GCJ ETHICON ENDO-SURGERY, INC. N4LY9T

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR NO OTHER THERAPIES