BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENICON 2EZEE SPECIMEN RETRIEVAL BAG

    MDR report key: 10359168 · Received August 3, 2020

    Report

    Report Number
    3002590791-2020-00050
    Event Type
    Malfunction
    Date Received
    August 3, 2020
    Date of Event
    June 12, 2019
    Report Date
    August 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

    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

    THIS WAS THE VERY FIRST CASE DONE WITH NEW BAG. IT WAS DONE LATE IN THE EVENING AND I WAS NOT PRESENT. ALL STAFF WAS IN-SERVICED. BAG RUPTURED AS BOTTOM AS SPECIMEN WAS BEING EXTRACTED. I WAS TOLD THAT OR IS "IN AN UPROAR" BECAUSE WE TOLD THEM THIS BAG IS STRONGER AND SHOULD NOT BURST WTIH NORMAL USAGE. FIRST CASE, IT BURST. THE BAG WAS USED IN A NORMAL WAY- SPECIMEN WAS NORMAL. BAG RIPPED AT DISTAL TIP. A TOTAL OF 3 GENICON BAGS WERE OPENED AND USED TO RETRIEVE THE STONES AND GALL BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822825 GENICON 2EZEE SPECIMEN RETRIEVAL BAG SPECIMEN RETRIEVAL BAG GCJ GENICON, INC. 550-000-200 J0449-B 00877972007289

    Patients

    Seq Age Sex Outcome Treatment
    1