BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR CURVED CUTTER STAPLER

    MDR report key: 1120889 · Received August 18, 2008

    Report

    Report Number
    3005075853-2008-01250
    Event Type
    Injury
    Date Received
    August 18, 2008
    Date of Event
    July 29, 2008
    Report Date
    August 5, 2008
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 08/18/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ENDOSCOPIC LOW ANTERIOR RESECTION WAS PLANNED/LEFT COLON RESECTION. AFTER EXPOSURE AND DIRECT EXAMINATION THE SURGEON DECIDED TO REMOVE AS LOW AS POSSIBLE AT THE SIGMOID LEVEL. THE STAPLER WAS USED ON THE DISTAL END AND AS PER THE IFU THE STAPLE LINES WERE INSPECTED AND STAPLES APPEARED TO BE FORMED. (NOTE: THE SURGEONS USED A SCALPEL AS THEY WILL DO WITH ANOTHER DEVICE ON THE CEPHALAD PART OF THE SIGMOID). ANOTHER DEVICE WAS INTRODUCED IN THE RECTUM. HALF OF THE STAPLE LINE OF THE SIGMOID COLON OPENED LATERALLY. THEY COULD NO LONGER VISUALIZE THE STAPLE LINE TO CONFIRM IF THE STAPLES WERE FORMED. NO EXPLANATION COULD BE PROVIDED AS TO WHY THE STAPLE LINE APPEARED IN TACT AFTER FIRING, BUT THE STAPLE LINE OPENED ON INSERTION OF THE SECOND DEVICE. IT WAS MENTIONED THAT THIS WAS A HEMODIALYSIS PT. SUTURES WERE USED TO CLOSE THE INCISION. THE CASE WAS CONVERTED TO AN OPEN ILEOSTOMY. THE OPENED PROCEDURE AND ILEOSTOMY WERE NOT PLANNED FOR THIS SURGERY. SURGERY WAS PROLONGED 60 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR CURVED CUTTER STAPLER GDW ETHICON ENDO-SURGERY, LLC NA C4CY8C

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention