BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENISTRONG SPECIMEN RETRIEVAL BAG

    MDR report key: 10714806 · Received October 21, 2020

    Report

    Report Number
    3002590791-2020-00106
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Date of Event
    September 21, 2020
    Report Date
    October 21, 2020
    Manufacturer
    GENICON, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K180836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER IS UNKNOWN. DEVICE IS NOT AVAILABLE FOR RETURN. ONE (1) PHOTOGRAPH WAS PROVIDED.

    Description of Event or Problem · 1

    DEVICE (PRODUCT CODE 550-000-003) REMOVED FROM PACKAGING DURING SURGERY. BAG DEPLOYED (NOT IN PATIENT) AND IT "BROKE," BIASING ARMS CAME OUT OF BAG. OPENED A NEW 550-000-003 AND COMPLETED PROCEDURE. CAUSED A DELAY, BUT NO HARM TO PATIENT. DEVICE WAS DISCARDED, BUT A PICTURE WAS TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180616 GENISTRONG SPECIMEN RETRIEVAL BAG SPECIMEN RETRIEVAL BAG GCJ GENICON, INC. 550-000-003

    Patients

    Seq Age Sex Outcome Treatment
    1