BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENICON 2EZEE SPECIMEN RETRIEVAL BAG

    MDR report key: 10382943 · Received August 7, 2020

    Report

    Report Number
    3002590791-2020-00044
    Event Type
    Malfunction
    Date Received
    August 7, 2020
    Date of Event
    May 31, 2019
    Report Date
    August 7, 2020
    Manufacturer
    GENICON, INC.
    Product Code
    GCJ
    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 COMPLAINT FILES BETWEEN (B)(6) 2017 THROUGH (B)(6) 2019.

    Description of Event or Problem · 1

    WHILE DOING A LAP CHOLI PROCEDURE, DR. WAS IN THE PROCESS OF REMOVING THE DEPLOYED 2EZEE BAG, WHEN THE BAG BROKE AT THE BOTTOM. THE GALLBLADDER DROPPED BACK INTO THE ABDOMEN AND THE BAG WAS EASILY REMOVED. THE GALLBLADDER WAS THEN REMOVED USING A GRASPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845004 GENICON 2EZEE SPECIMEN RETRIEVAL BAG SPECIMEN RETRIEVAL BAG GCJ GENICON, INC. 550-000-200 J0317-A

    Patients

    Seq Age Sex Outcome Treatment
    1