BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR CURVED CUTTER STAPLER

    MDR report key: 1791831 · Received August 5, 2010

    Report

    Report Number
    3005075853-2010-04467
    Event Type
    Injury
    Date Received
    August 5, 2010
    Date of Event
    July 7, 2010
    Report Date
    July 14, 2010
    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
    FL, US
    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. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION, ON THE DISTAL TRANSECTION, THE DISTAL STAPLE LINE WAS OPENED. WHEN THE SURGEON WAS CHECKING THE DISTAL STUMP, HE DID NOT SEE ANY STAPLES. SUTURES WERE USED TO COMPLETE THE CASE. THE PATIENT WAS TAKEN BACK INTO THE OPERATING ROOM THAT NIGHT FOR BLEEDING AT THE DISTAL AREA WHERE THE SURGEON HAD USED SUTURES. THERE WAS NO BLOOD TRANSFUSION GIVEN. THE PATIENT IS FINE AND MAY BE RELEASED SOMETIME DURING THE WEEK OF (B)(6) 2010. ADDITIONAL INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR CURVED CUTTER STAPLER GDW STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC NA G4T2OE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R CARTRIDGE