BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENICON 2EZEE POLY SPECIMEN RETRIEVAL BAG

    MDR report key: 10342145 · Received July 29, 2020

    Report

    Report Number
    3002590791-2020-00037
    Event Type
    Malfunction
    Date Received
    July 29, 2020
    Date of Event
    March 26, 2019
    Report Date
    July 29, 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, AND IS ASSOCIATED WITH COMPLAINT (B)(4) (ADDENDED COMPLAINT FILE (B)(4)). THE DEVICE WAS NOT RETURNED TO GENICON, INC. FOR EVALUATION. NO PHYSICAL OR VISUAL EVALUATION COULD BE PERFORMED; COMPLAINANT DID NOT TAKE PICTURES AND DID NOT KEEP THE SAMPLE FOR RETURN.

    Description of Event or Problem · 1

    BAG WAS BEING USED BY DOCTOR IN A LAPAROSCOPIC CHOLECYSTECTOMY. WHEN REMOVING THE SPECIMEN THE SEAM ON THE END OF THE BAG SPLIT ALLOWING THE BAG TO BE REMOVED WHILE THE SPECIMEN REMAINED IN THE PATIENT. NOTE: DISTRIBUTOR WHO REPORTED THE COMPLAINT, PROVIDED FOLLOW UP INFORMATION THAT THE SURGEON WAS ABLE TO PULL OUT THE SPECIMEN WITH A KELLY FORCEPS, AND THAT THE PROCEDURE WAS DELAYED FOR A FEW MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806336 GENICON 2EZEE POLY SPECIMEN RETRIEVAL BAG SPECIMEN RETRIEVAL BAG GCJ GENICON, INC. 550-000-200 I9873-A 00877972007289

    Patients

    Seq Age Sex Outcome Treatment
    1