BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR CURVED CUTTER STAPLER

    MDR report key: 1993413 · Received February 16, 2011

    Report

    Report Number
    3005075853-2011-00637
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 31, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH TWO RELOADS PRESENT. RELOAD A WAS RECEIVED FULLY LOADED WITH STAPLES, WITH THE WASHER UNCUT AND WITH THE DRIVERS AND KNIFE RECESSED BELOW THE CARTRIDGE DECK; RELOAD B WAS RECEIVED FULLY FIRED AND WITH THE WASHER CUT. THE RETURNED RELOAD A WAS PULLED OUT OF THE DEVICE AND PLACED BACK ON; THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH THE RETURNED RELOAD AND IT 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 CARTRIDGE LOCKOUT WERE FUNCTIONAL, AND THE DEVICE FIRED WITHOUT ANY DIFFICULTIES. 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 AN ULTRA LOW ANTERIOR RESECTION PROCEDURE, THE DEVICE WAS FIRED ON THE RECTUM, CUTTING BUT WHEN THEY TRIED TO REMOVE IT, THEY REALIZED THAT THE RECTAL STUMP WAS NOT STAPLED IN A CORRECT WAY AND THERE WAS LEAKAGE OF INTESTINAL CONTENTS IN THE PELVIC CAVITY. THEY TRIED TO MAKE A LOWER SECTION WITH CONTOUR, BUT THERE WAS NO TISSUE FOR IT. THEY HAD TO MAKE IT BY HAND BUT THERE WERE SOME LEAKAGE AGAIN. THE PATIENT HAD TO HAVE A COLOSTOMY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REQUESTED ON (B)(6) 2011 AND NO ADDITIONAL INFORMATION WAS RECEIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R CARTRIDGE