BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON ARTICULATING ENDOSCOPIC LINEAR CUTTER

    MDR report key: 1806846 · Received August 16, 2010

    Report

    Report Number
    1806846
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    August 14, 2010
    Report Date
    August 14, 2010
    Manufacturer
    JOHNSON & JOHNSON
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS DIAGNOSED WITH AN ACUTE APPENDICITIS. HE WAS ADMITTED AND SCHEDULED FOR AN APPENDECTOMY. DURING THE APPENDECTOMY ON (B)(6) 2010, THE SURGEON ENCOUNTERED A PROBLEM WITH THE ETHICON LINEAR CUTTER WHEN HE TRIED TO STAPLE THE AREA. THE SURGEON WAS PERFORMING THE APPENDECTOMY AND DURING CLOSING OF THE PROCEDURE, HE WAS STAPLING THE CECUM USING AN ETHICON 45MM STAPLER. ON FIRST USE, HE NOTED THERE WAS A GREAT DEAL OF RESISTANCE ON THE LEVER WHEN PLACING STAPLES. THE STAPLER HAS TWO LEVERS, THE FIRST IS WHITE AND IS USED TO CLAMP STAPLER OVER TISSUE AND THE SECOND IS BLACK. THE BLACK LEVER FIRES THE STAPLES. REMEMBERING A SIMILAR EVENT WITH THIS TYPE OF STAPLER, THE SURGEON STOPPED AND EXAMINED THE AREA OF CLOSURE AND DISCOVERED THAT THE STAPLES WERE NOT SEATED PROPERLY. HE REMOVED THE STAPLES AND WITH A NEW STAPLER CLOSED THE WOUND. THE SURGEON ADVISED NO INJURY AND THE SURGERY WAS EXTENDED BY 10 MINUTES. THE SURGERY WAS COMPLETED WITH NO FURTHER COMPLICATIONS AND THE PT WAS DISCHARGED HOME ON (B)(96) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ARTICULATING ENDOSCOPIC LINEAR CUTTER ENDOSCOPIC CUTTER/STAPLER GDW JOHNSON & JOHNSON ATS45 G4TD9A

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other