BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CDH 29 PROXIMATE IL

    MDR report key: 1100544 · Received August 5, 2008

    Report

    Report Number
    MW5007890
    Event Type
    Injury
    Date Received
    August 5, 2008
    Date of Event
    July 18, 2008
    Report Date
    July 23, 2008
    Manufacturer
    ETHICON ENDO SURGERY, DIVISION OF J&J
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PRE OP DX: RECTAL MASS. PROCEDURES: LAPAROSCOPIC SPLENIC FLEXURE MOBILIZATION. RESECTION RECTOSIGMOID, RESECTION ADDITIONAL MARGIN. THE STAPLER ONCE OPENED WAS NOTED TO COME THROUGH RIGHT IN THE MIDDLE OF THE STAPLE LINE. THE STAPLER MISFIRED AND THE PATIENT WAS LEFT WITH A LARGE CIRCULAR HOLE IN THE RECTUM AND THE PROXIMAL END COLON WAS OPEN NECESSITATING A COLOSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CDH 29 PROXIMATE IL CURRED INTRALUMENAL STAPLER GDW ETHICON ENDO SURGERY, DIVISION OF J&J CDH 29 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization