BEUDAMED
    FDA Adverse Event Death Summary report: N

    ECHELON*FLEX60

    MDR report key: 1579681 · Received January 18, 2010

    Report

    Report Number
    3005075853-2010-00220
    Event Type
    Death
    Date Received
    January 18, 2010
    Date of Event
    December 23, 2009
    Report Date
    January 8, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A LEFT LOBECTOMY PROCEDURE, THE INITIAL FIRING OF THE STAPLER WITH A WHITE CARTRIDGE OVER PULMONARY VEIN CLOSE TO ENTRY POINT OF ATRIUM. NO DIFFICULTY ENCOUNTERED UPON CLOSING, FIRING OR OPENING THE DEVICE ON FIRST FIRING. THE INSTRUMENT WAS THEN USED FOR A TOTAL OF SIX FIRINGS FOR COMPLETION OF PROCEDURE ACROSS VESSELS AND BRONCHUS WITH APPROPRIATE COLORED CARTRIDGES. NO DIFFICULTY REPORTED FOR SUBSEQUENT FIRINGS OF DEVICE APART FROM AN INCREASED FORCE REQUIRED WHEN FIRING ACROSS BRONCHUS. PROCEDURE COMPLETED. UPON TRANSFERRING PATIENT FROM TABLE TO BED, LARGE DROP IN PATIENT¿S BLOOD PRESSURE RECORDED. PATIENT WAS THEN RE-OPERATED ON. HOWEVER, LARGE BLOOD LOSS HAD OCCURRED RESULTING IN PATIENT DEATH. UPON INSPECTION BY THE SURGEON, IT WAS NOTED THAT THE BLOOD LOSS HAD OCCURRED FROM THE PULMONARY VEIN. AS THE SURGEON HAD REPORTED THIS INCIDENT, ALSO NOTING IT WAS A BULKY TUMOR IN THE REGION BUT WAS NOT CERTAIN AS TO THE CAUSE. DEVICE WAS KEPT; HOWEVER, IT APPEARS RELOADS WERE DISPOSED OF. ONE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK F4PR4D

    Patients

    Seq Age Sex Outcome Treatment
    1 Death WHITE RELOAD