BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPOUCH RETRIEVER SPEC BAG

    MDR report key: 1080021 · Received July 17, 2008

    Report

    Report Number
    3005075853-2008-00569
    Event Type
    Malfunction
    Date Received
    July 17, 2008
    Report Date
    June 24, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K011501
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE POUCH RIPPED AWAY FROM THE TOP STABILIZATION WIRE OF THE POUCH AS THE GALLBLADDER WAS BEING PULLED OUT OF THE ABDOMINAL PORTAL. THE HANDLE OF THE ENDOPOUCH WAS LOCKED IN THE OPEN POSITION SO THAT IT COULD NOT BE REMOVED FROM THE ABDOMEN WITHOUT MAKING AN INCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPOUCH RETRIEVER SPEC BAG GCJ ETHICON ENDO-SURGERY, LLC. NA E4KP24

    Patients

    Seq Age Sex Outcome Treatment
    1