BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2EZEE

    MDR report key: 10250254 · Received July 9, 2020

    Report

    Report Number
    3002590791-2020-00033
    Event Type
    Malfunction
    Date Received
    July 9, 2020
    Date of Event
    December 5, 2018
    Report Date
    July 8, 2020
    Manufacturer
    GENICON, INC.
    Product Code
    GCJ
    UDI-DI
    00877972007289
    PMA / PMN Number
    K180836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTABLE EVENT WAS IDENTIFIED DURING A REVIEW OF COMPLAINTS RECEIVED BETWEEN OCTOBER 2017 AND DECEMBER 2019. A ROOT CAUSE FOR THE BROKEN BAG COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CASE WAS A LAPAROSCOPIC CHOLECYSECTOMY. THE 550-000-200 SPECIMEN BAG WAS SUCCESSFULLY DEPLOYED AND THE PATIENT'S GALLBLADDER WAS PLACED IN THE BAG WITHOUT ISSUE. THE STRING WAS RELEASED FROM THE HANDLE AND BAG WAS CINCHED CLOSED, FOLLOWED BY THE REMOVAL OF THE INTRODUCER AND TROCAR, LEAVING JUST THE BAG/SPECIMEN IN THE ABDOMEN. THE SURGEON WAS ABLE TO FAIRLY EASILY PULL THE BAG AND SPECIMEN THROUGH AND NEARLY HAD THE ENTIRE BAG AND SPECIMEN OUT WHEN THE BAG RUPTURED, LEAVING THE GALLBLADDER HALF WAY OUT. CLAMPS WERE PLACED TO TRY AND RETRIEVE THE SPECIMEN IN IT'S ENTIRETY BUT THAT CAUSED THE GALLBLADDER TO RUPTURE AS WELL AND ONLY HALF OF IT WAS RETRIEVED. THE SURGEON REINSERTED THE 10MM TROCAR THROUGH THE SAME DEFECT AND THAT PUSHED THE REMAINING HALF THE GALLBLADDER AND LARGE STONES BACK INTO VISUALIZATION FROM WITHIN THE ABDOMEN. THE SURGEON THEN DEPLOYED A SECOND BAG TO RETRIEVE IT AND ALL THE REMAINING STONES THAT HAD FALLEN INTO THE ABDOMINAL CAVITY. THE BAG RUPTURE CAUSED A DELAY IN THE PROCEDURE, ADDED APPROXIMATELY AN ADDITIONAL 20 MIN TO THE CASE TIME, AND REQUIRED A SECOND BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715974 2EZEE SPECIMEN RETRIEVAL BAG GCJ GENICON, INC. 500-000-200 I9845-A 00877972007289

    Patients

    Seq Age Sex Outcome Treatment
    1