BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR CURVED CUTTER STAPLER

    MDR report key: 2133958 · Received June 20, 2011

    Report

    Report Number
    3005075853-2011-02505
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    April 12, 2011
    Report Date
    May 4, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (DEVICE B): METHOD: DAMAGED CARTRIDGE.(B)(4). DEVICE (A) WAS RECEIVED IN GOOD VISUAL CONDITIONS AND WITHOUT A CARTRIDGE PRESENT. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH AN ENGINEERING SAMPLE RELOAD AND THE DEVICE FIRED, FORMING ALL STAPLES AND CUTTING 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. DEVICE (B) WAS RECEIVED IN GOOD VISUAL CONDITIONS AND WITH A CARTRIDGE LOADED ON THE DEVICE; THE CARTRIDGE WAS RECEIVED FULLY FIRED AND WAS NOTED TO HAVE THE REAR CAP BROKEN; IT IS POSSIBLE THAT THE CARTRIDGE WAS REMOVED FROM THE DEVICE AND WAS NOT PROPERLY RELOADED INTO THE DEVICE, CAUSING THE DAMAGE TO THE REAR CAP. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH THE RETURNED CARTRIDGE AND THE DEVICE FUNCTIONED 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 CARTRIDGE LOCKOUT WERE FUNCTIONAL. DURING THE ANALYSIS, THE RETAINING PIN FUNCTIONED AS INTENDED. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE REAR CAP BECAME DAMAGED, IT SHOULD BE NOTED THAT A 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4). IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN AUTOMATED VISION SYSTEM, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COLON RESECTION PROCEDURE, THE FIRST DEVICE WAS FIRED TWO TIMES AND THE STAPLE LINE WAS INADEQUATE. A SECOND DEVICE WAS PULLED AND THE SAME THING OCCURRED WITH AN INADEQUATE STAPLE LINE ON TWO FIRINGS. THE SURGEON OVER SEWED THE STAPLE LINE. DURING THE PROCEDURE THREE DIFFERENT CDH29 DEVICES WERE PULLED AND FIRED AND THE STAPLE LINE ON ALL THREE DEVICES WAS NON CONTINUITY. THE SURGEON OVER SEWED THE STAPLE LINE TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR CURVED CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA H43A20

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR CARTRIDGE