BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR CURVED CUTTER STAPLER

    MDR report key: 2080032 · Received May 6, 2011

    Report

    Report Number
    3005075853-2011-01839
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 14, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K040038
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED CARTRIDGE. THE ANALYSIS RESULTS SHOWED THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH ONE RELOAD PRESENT. THE RELOAD WAS RECEIVED VOID OF STAPLES AND WITH THE ANVIL AND WASHER DETACHED AND MISSING. IT SHOULD BE NOTED THAT TO RELOAD THE DEVICE, INSERT THE NEW RELOAD INTO THE METAL HOUSING AND SNAP INTO POSITION. THE TRACKS ON EACH SIDE OF THE RELOAD SHOULD BE USED AS GUIDES TO ALIGN THE RELOAD WITHIN THE JAWS OF THE INSTRUMENT. WHEN THE RELOAD IS PROPERLY ALIGNED, PUSH THE RELOAD INTO THE INSTRUMENT UNTIL IT IS FULLY SEATED. REMOVE THE STAPLE RETAINER. CHECK THAT THE RELOAD IS HELD FIRMLY WITHIN THE JAWS. IF THE RELOAD IS REMOVED FROM THE DEVICE, WHETHER THE RELOAD IS SPENT OR NOT, AND IF THE STAPLE RETAINER HAS ALREADY BEEN REMOVED FROM THE RELOAD, THE RELOAD CANNOT BE RELOADED INTO THE DEVICE. PLEASE REFERENCE THE INSTRUCTIONS FOR USE FOR ADDITIONAL INFORMATION. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED THE STAPLES AS INTENDED. THE CUT LINE WAS COMPLETE, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE DEVICE LOCKOUT AND THE RELOAD LOCKOUT WERE FUNCTIONAL. AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN (B)(4), AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AFTER THE DEVICE WAS FIRED, ONLY A SMALL PART OF THE STAPLES FORMED, AND THE LINE WAS CUT COMPLETELY. BECAUSE THE STATION WAS HIGH, THE SURGEON USED HAND SEWING TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCE FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR CURVED CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4U82J

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE