BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPOUCH SPEC BAG

    MDR report key: 2133761 · Received June 20, 2011

    Report

    Report Number
    3005075853-2011-02493
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 26, 2011
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT ONLY THE BAG WITH THE SUTURE CUT WERE RECEIVED FOR ANALYSIS. DURING EVALUATION THE BAG WAS NOTED TORN AT THE BOTTOM END (NOT AT THE SEAMS). THE TORN PORTION WAS NOTED STRETCHED. EACH DEVICE IS 100% VISUALLY INSPECTED AT TWO DIFFERENT ASSEMBLY OPERATIONS PRIOR TO SHIPMENT AND DAMAGE OF THIS MAGNITUDE WOULD HAVE BEEN DETECTED DURING THIS INSPECTION. HOWEVER, A POTENTIAL CAUSE OF THE TORN BAG IS ATTEMPT TO REMOVE THE BAG WITH SPECIMEN THROUGH THE TROCAR OR FORCE THE BAG THROUGH THE ACCESS SITE AS THIS MAY LEAD TO BAG RUPTURE AND SPILLAGE OF CONTENTS. THE FOLLOWING OPTIONS ARE RECOMMENDED IN ORDER TO AVOID THIS KIND OF ISSUE: REMOVE THE INSTRUMENT, SPECIMEN BAG, AND TROCAR TOGETHER FORM THE ACCESS SITE (DO NOT PULL THE SLIP KNOT). REMOVE THE INSTRUMENT FROM THE TROCAR, FOLLOWING BY THE SPECIMEN BAG WITH THE TROCAR. REMOVE THE INSTRUMENT, TROCAR AND SPECIMEN BAG SEPARATELY FROM THE ACCESS SITE. IF THE BAG WITH THE SPECIMEN CANNOT BE REMOVED THROUGH THE ACCESS SITE, CAREFULLY ENLARGE THE ACCESS SITE TO FACILITATE EASY BAG REMOVAL. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. WHILE REMOVING THE POUCH WITH GALL BLADDER INSIDE THE POUCH. A HOLE OPENED IN THE BAG AND THE GALL BLADDER FELL BACK INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPOUCH SPEC BAG LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA H43F15

    Patients

    Seq Age Sex Outcome Treatment
    1