BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENISTRONG

    MDR report key: 10230983 · Received July 4, 2020

    Report

    Report Number
    3002590791-2020-00076
    Event Type
    Malfunction
    Date Received
    July 4, 2020
    Date of Event
    May 28, 2015
    Report Date
    July 4, 2020
    Manufacturer
    GENICON, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K180836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTABLE EVENT WAS IDENTIFIED DURING INTERACTION AND DISCUSSIONS WITH FDA ON 2020-06-10. A PHOTOGRAPH WAS PROVIDED SHOWING THE BIASING ARMS ARE OPEN AND THE BAG IS NOT ATTACHED.

    Description of Event or Problem · 1

    FLEXIBLE METAL RINGS WERE NOT ATTACHED TO THE SPECIMEN RETRIEVAL BAG. WHEN DEPLOYING THE SPECIMEN RETRIEVAL BAG, THE METAL ARMS OPENED OUTSIDE OF THE BAG. THE SURGEON TRIED TO USE ANOTHER DEVICE AND THE SAME THING HAPPENED. THE ARMS DEPLOYED INSIDE THE BAG ON THE THIRD DEVICE THAT HE TRIED. THIS REPORT IS FOR THE FIRST DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694947 GENISTRONG SPECIMEN RETRIEVAL BAG GCJ GENICON, INC. 550-000-003 I6707-E

    Patients

    Seq Age Sex Outcome Treatment
    1