BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR CURVED CUTTER STAPLER

    MDR report key: 1253009 · Received December 3, 2008

    Report

    Report Number
    3005075853-2008-03406
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    October 23, 2008
    Report Date
    November 13, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 12/03/2008. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    TRACKING # (B)(4). DATE SENT: 02/04/2009. EVALUATION SUMMARY: THE ANALYSIS RESULTS SHOWED THAT THE CS40G DEVICE WAS RECEIVED IN GOOD VISUAL CONDITIONS AND WITH A 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. 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.

    Additional Manufacturer Narrative · 1

    TRACKING # (B)(4). DATE SENT: 02/20/2009.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, THE ANAL SIDE OF THE STAPLER MISFIRED WITH AN OPEN STAPLE LINE DISTALLY. THE SURGEON HAND SEWED THE ANASTOMOSIS. THE PATIENT RECEIVED A PERMANENT COLOSTOMY.

    Description of Event or Problem · 1

    A PERMANENT COLOSTOMY WAS NOT REQUIRED AT THE TIME OF SURGERY. THE SURGEON PERFORMED A TEMPORARY HAND-SEWN ANASTOMOSIS OF THE COLON. THE SURGEON DID NOT MENTION THAT THERE WAS ANY DIFFICULTY FIRING THE DEVICE BUT HE DID MENTION THAT BECAUSE OF WHERE IT WAS, IT WAS EXTREMELY HARD TO VISUALIZE THE HEAD OF THE STAPLER. HE MENTIONED THAT HE FELT WITH HIS HAND AND NOTICED THAT THE RECTUM WAS FULLY ENCIRCLED BY THE DEVICE AND HE DIDN'T USE EXCESSIVE FORCE TO FIRE. THE SURGEON DID NOT OPEN ANOTHER DEVICE; HE DECIDED TO HAND-SEW. HE TOOK THE COLON OUT THROUGH THE ANUS TO SEW THE ANASTOMOSIS. THIS HAND-SEWN ANASTOMOSIS WILL BE REASSESSED. IF, UPON RE-INSPECTION, THE SURGEON DETERMINES THAT THE SPHINCTER HAS BEEN DAMAGED, HE WILL GIVE THE PATIENT A PERMANENT COLOSTOMY. THE SURGEON HAS INDICATED THAT THE ANASTOMOSIS IS FINE. BECAUSE THE SURGERY WAS DELAYED, THE PATIENT WAS UNDER ANESTHETIC FOR A LONGER PERIOD OF TIME AND THE PATIENT DEVELOPED FEMORAL NERVE PALSY DUE TO PROLONGED RETRACTION. THE PATIENT CONTINUED TO HAVE THIS PALSY ALTHOUGH THE SURGEON IS OPTIMISTIC THAT NERVE SENSITIVITY WILL EVENTUALLY RETURN. THE PATIENT WAS RELATIVELY YOUNG AND RECEIVED NO NEO-ADJUVANT THERAPY. TISSUE WAS IN GOOD CONDITION. THE PATIENT CONTINUES TO HAVE NERVE PALSY BUT IS OTHERWISE FINE. THE PATIENT CONTINUES TO HAVE SOME NUMBNESS DUE TO THE SURGEON HITTING THE FEMORAL NERVE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR CURVED CUTTER STAPLER GDW ETHICON ENDO-SURGERY, LLC NA E4LU39

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Unknown Required Intervention