BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON 60 ENDOPATH STAPLER

    MDR report key: 1071387 · Received July 8, 2008

    Report

    Report Number
    3005075853-2008-00320
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    May 30, 2008
    Report Date
    June 26, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K051002
    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

    DATE SENT: 07/08/2008. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SPLENECTOMY, WHILE USING A RELOAD, THE DEVICE FIRED, BUT WOULD NOT RELEASE FROM THE TISSUE. THE SURGEON TRIED THE RELEASE BUTTON SEVERAL TIMES AS WELL AS THE EMERGENCY RELEASE BUTTON. AFTER SEVERAL ATTEMPTS, THE STAPLER CAME LOOSE WITH THE JAWS STILL CLOSED. AT THIS POINT, THERE WAS BLOOD POOLING UNDER THE SPLEEN. AFTER THIS EVENT, THE SURGEON MADE THE DECISION TO OPEN TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 ENDOPATH STAPLER GDW ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention