BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENICON 2EZEE POLY SPECIMEN RETREIVAL BAG

    MDR report key: 9925732 · Received April 4, 2020

    Report

    Report Number
    3002590791-2020-00017
    Event Type
    Malfunction
    Date Received
    April 4, 2020
    Date of Event
    February 27, 2020
    Report Date
    April 3, 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

    Description of Event or Problem · 1

    (B)(6), THE GENERAL SURGERY COORDINATOR, CALLED DISTRIBUTOR ON (B)(6) 2020 TO REPORT A PROBLEM WITH THE GENICON 2EZ POLY BAG. THEY REPORTED THAT DURING A LAP CHOLE WHEN THE CINCHED BAG, CONTAINING THE SPECIMEN, WAS PULLED UP TO THE TROCAR INCISION SITE FOR REMOVAL, THE BOTTOM OF THE BAG SEPARATED AND THE CONTENTS INCLUDING THE GALL BLADDER AND NUMEROUS STONES WERE RELEASED INTO THE ABDOMEN. THEY PROCEEDED TO REMOVE THE DEBRIS WHICH ADDED 30-45 MINUTES TO THE CASE. NO PHOTOGRAPHS WERE AVAILABLE BECAUSE THE BAG WAS THROWN AWAY AFTER THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389620 GENICON 2EZEE POLY SPECIMEN RETREIVAL BAG 2EZEE GCJ GENICON, INC. 550-000-200 J0561-B 00877972007289

    Patients

    Seq Age Sex Outcome Treatment
    1