BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENICON 2EZEE

    MDR report key: 10387875 · Received August 10, 2020

    Report

    Report Number
    3002590791-2020-00053
    Event Type
    Malfunction
    Date Received
    August 10, 2020
    Date of Event
    July 2, 2019
    Report Date
    August 10, 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 OCTOBER 2017 THROUGH DECEMBER 2019.

    Description of Event or Problem · 1

    LAP CHOLE CASE WITH THE DOCTOR USING THE NEW 550-000-200 BAG AT THE HOSPITAL. THE CUSTOMER SAID SEVERAL DOCTORS COMPLAINED ABOUT THE QUALITY OF THE ORIGINAL POLY BAG, AND PREVIOUSLY HAD 2 TORN BAGS BUT THEY DID NOT NOTE THE ITEM OR LOT NUMBERS. SO WE CONVERTED TO THE NEW BAGS IN AN ATTEMPT TO SAVE THE ACCOUNT. IN THE FIRST CASE WHILE TRIALING THE NEW GENICON BAG, THE BAG TORE WHILE TRYING TO REMOVE FROM PATIENT. THE TEAR WAS NEAR THE BOTTOM OF THE BAG, AND THE STONE FELL BACK INTO THE ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850020 GENICON 2EZEE POLY SPECIMEN RETREIVAL BAG GCJ GENICON, INC. 550-000-200 J0408-B 00877972007289

    Patients

    Seq Age Sex Outcome Treatment
    1