BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR CUTTER STAPLER

    MDR report key: 3931703 · Received July 14, 2014

    Report

    Report Number
    3005075853-2014-04906
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: PHOTOGRAPHIC CONCLUSION: BASED ON THE PHOTOGRAPHIC EVIDENCE, THE BELIEF IS THAT THE COMPLICATION WAS THE RESULT OF EITHER AN INCOMPLETE FIRING STROKE OR EXCESSIVE TISSUE IN THE JAWS. HANDS ON ANALYSIS OF THE DEVICE MAY PROVIDE THE EVIDENCE NECESSARY TO CONFIRM THE ROOT CAUSE OF THE COMPLICATION.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS SHOWED THAT THE CS40G DEVICE WAS RECEIVED IN GOOD VISUAL CONDITIONS AND WITH A CARTRIDGE RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED VOID OF STAPLES, WITH THE WASHER COMPLETELY CUT, WITH THE DRIVERS EXPOSED AND WITH THE KNIFE RECESS BELOW THE CARTRIDGE DECK. IN ADDITION ANOTHER CARTRIDGE WAS RECEIVED FULLY FIRED. 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. A BATCH RECORD REVIEW WAS PERFORMED AND THE BATCH HAD NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE THE SURGEON MANUALLY PUSHED THE PIN ACROSS AND TRAVELLED THE CONTOUR DOWN THE BOWEL. HE CLOSED THE GUN EASILY, WAITED 30 SECONDS AND THEN SQUEEZED THE FIRING TRIGGER, IT FELT NORMAL. ON REMOVING THE GUN IT WAS DISCOVERED THAT THE KNIFE HAD NOT CUT AND THE STAPLES WERE VERY BIG B SHAPES. THE CONTOUR WAS RELOADED WITH A GREEN CARTRIDGE AGAIN MANUAL PLACEMENT OF PIN, TRAVELLED DOWN BOWEL, CLOSED, WAITED 30 SECONDS AND THE FIRED. ONCE AGAIN THE CONTOUR HAD NOT TRANSECTED THE TISSUE AND THE STAPLES WERE BIG B'S. ANOTHER CONTOUR WAS OPENED AND USED AND IT FIRED AND CUT AS EXPECTED. NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411200 CONTOUR CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOADS - CR40G X2