BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR CURVED CUTTER STAPLER

    MDR report key: 2955652 · Received February 11, 2013

    Report

    Report Number
    3005075853-2013-00539
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 16, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT THE 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. 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. 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. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW RECTAL CANCER PROCEDURE, THE SURGEON USED THE DEVICE TO STAPLE THE RECTUM AND FOUND THAT THE DISTAL PART WAS NOT CLOSED AFTER THE FIRING. THE SURGEON HAD TO CUT THE ANUS, USED HAND SEWING TO COMPLETE THE PROCEDURE AND MADE THE FISTULA FOR THE PATIENT. THE PATIENT HAS NOT BEEN DISCHARGED YET. THE PATIENT LOST ANUS. ADDITIONAL FOLLOW UP IS BEING CONDUCTED. IF ADDITIONAL DETAILS BECOME AVAILABLE A 3500 A SUPPLEMENTAL WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58453 CONTOUR CURVED CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4AG9Z

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention