BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPOUCH RETRIEVER SPEC BAG

    MDR report key: 1823877 · Received November 30, 2007

    Report

    Report Number
    1527736-2007-08127
    Event Type
    Malfunction
    Date Received
    November 30, 2007
    Date of Event
    November 5, 2007
    Report Date
    November 5, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GCJ
    PMA / PMN Number
    K011501
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: THE POUCH WAS RECEIVED WITH THE BAG CUT AT THE PROXIMAL END. THE SUTURE WAS NOTED TO BE CUT AS WELL. ALL OTHER COMPONENTS WERE PRESENT AND IN GOOD CONDITION. AS EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING THE MANUFACTURING PROCESS, NO CONCLUSION COULD BE REACHED AS TO HOW THE DAMAGE TO THE DEVICE OCCURRED. 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. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP GYN PROCEDURE, A SMALL PIECE OF THE BAG CAME OFF. IT DID NOT FALL INTO THE PT. USED A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPOUCH RETRIEVER SPEC BAG GCJ ETHICON ENDO SURGERY, INC. (CINCINNATI) NA D4HX6F

    Patients

    Seq Age Sex Outcome Treatment
    1