BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENICON 2EZEE RETRIEVAL BAG

    MDR report key: 10385373 · Received August 10, 2020

    Report

    Report Number
    3002590791-2020-00055
    Event Type
    Malfunction
    Date Received
    August 10, 2020
    Date of Event
    July 31, 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 (B)(6) 2017 THROUGH (B)(6) 2019.

    Description of Event or Problem · 1

    DOCTOR HAD THE POLY BAG OUT OF THE TROCAR SITE HALFWAY. HE THEN PROCEEDED TO PUT A CLAMP HORIZONTAL ACROSS THE BAG AND CLAMPED IT ABOUT HALF WAY AND ALL THE WAY ACROSS. HE THEN USED THE CLAMP AS A T-HANDLE AND PULLED ON IT AS LEVERAGE. THE BAG STARTED TO STRETCH AND RIGHT BEFORE THE GALL BLADDER CAME OUT THE BAG BROKE IN HALF. THE GALL BLADDER HOWEVER WAS STUCK WHERE DOCTOR COULD REACH INTO THE TROCAR SITE AND GRAP IT WITH SOME PICKUPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848227 GENICON 2EZEE RETRIEVAL BAG SPECIMEN RETRIEVAL BAG GCJ GENICON, INC. 550-000-200 J0468-B 00877972007289

    Patients

    Seq Age Sex Outcome Treatment
    1