BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR CURVED CUTTER STAPLER

    MDR report key: 1963171 · Received January 18, 2011

    Report

    Report Number
    3005075853-2011-00248
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    December 28, 2010
    Report Date
    December 29, 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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    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 (B)(4), AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. (B)(4). A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW RECTAL RESECTION PROCEDURE, THE SURGEON WAS USING THE DEVICE TO ANASTOMOSE THE TISSUE WHEN AFTER FIRING THE DEVICE, IT WAS ONLY CUT BUT NOT SEWED ON THE PROXIMAL AND DISTAL OF THE RECTUM. THE SURGEON DID A PURSE STRING TO FINISH THE PROCEDURE. THE PATIENT LOST 200ML OF BLOOD AND HAD A TRANSFUSION OF 300ML. THE SURGERY WAS EXTENDED TWO HOURS. THE PATIENT WAS FINE AND IN THE ICU. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    .

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other| R CARTRIDGE