BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GCJ LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

    MDR report key: 1459633 · Received May 21, 2009

    Report

    Report Number
    3005075853-2009-02986
    Event Type
    Malfunction
    Date Received
    May 21, 2009
    Date of Event
    April 28, 2009
    Report Date
    April 29, 2009
    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
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 05/21/2009. MISSING BAG. EVAL SUMMARY: NO CONCLUSION COULD BE REACHED BASED ON THE ANALYSIS RESULTS AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT, AS THE BAG WAS NOT RETURNED FOR ANALYSIS. THE POUCH DEVICE WAS RETURNED IN GOOD CONDITION AND FULLY DEPLOYED. WHILE WE WERE UNABLE TO RECREATE THE EVENT, WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. A BATCH RECORD REVIEW WAS PERFORMED, AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP APPENDECTOMY PROCEDURE, THE APPENDIX FELL THROUGH THE BOTTOM OF THE BAG WHILE ATTEMPTING TO REMOVE IT FROM THE ABDOMINAL CAVITY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GCJ LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC NA D4JR3L

    Patients

    Seq Age Sex Outcome Treatment
    1