BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPOUCH RETRIEVER SPEC BAG

    MDR report key: 1241091 · Received November 21, 2008

    Report

    Report Number
    3005075853-2008-03288
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    November 3, 2008
    Report Date
    November 3, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GCJ
    PMA / PMN Number
    K011501
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY PROCEDURE, UPON REMOVING THE POUCH, THE END OF THE BAG RIPPED. THE GALLBLADDER WAS REMOVED SUCCESSFULLY, BUT THE PIECE OF THE BAG REMAINED IN THE PATIENT. A LAPAROTOMY WAS DONE IN AN ATTEMPT TO RETRIEVE THE PIECE, IT COULD NOT BE LOCATED. THE PATIENT IS FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention