BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOPATH** ETS FLEX45

    MDR report key: 1691504 · Received May 17, 2010

    Report

    Report Number
    3005075853-2010-02606
    Event Type
    Death
    Date Received
    May 17, 2010
    Date of Event
    April 19, 2010
    Report Date
    April 20, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): INFORMATION IS UNAVAILABLE; DEVICE WAS DISCARDED. ADDITIONAL FOLLOW UP: SPOKE WITH THE SALES REP; HE HAD JUST MET WITH THE ASSISTING SURGEON. PATIENT WAS (B) (6) FEMALE. PATIENT HAD RENAL DISEASE AND A 2 YEAR EXPECTED SURVIVAL. THE PROCEDURE WAS BEING PERFORMED LAPAROSCOPICALLY WITHOUT HAND ASSIST. THE NEPHRECTOMY WAS ON THE RIGHT SIDE. THE RENAL VEIN HAD ALREADY BEEN TAKEN USING THE SAME DEVICE WITHOUT DIFFICULTY. THE RENAL ARTERY WAS THE LAST FIRING. THERE WERE SOME LYMPH NODES PRESENT AROUND THE ARTERY, BUT WAS NOT CONCERNED WITH THE FIRING. A LIGATURE DEVICE WAS USED FOR SOME DISSECTION, NO CLIPS WERE USED. THE STAPLER WAS PLACED ON THE RENAL ARTERY AND THEN RELEASED AND PLACED AGAIN. THE SURGEON WAITED 10 SECONDS, FIRED AND THEN WAITED 15 SECONDS PRIOR TO OPENING. UPON RELEASE, A GUSH OF ARTERIAL BLEEDING OCCURRED. DUE TO POSITIONING TO THE ARTERY, THE ARTERY RETRACTED AND THE SURGEON WAS UNABLE TO GRASP IT. THE PATIENT WAS IMMEDIATELY OPENED AND THE PATIENT WAS PACKED. AT THAT TIME THE PATIENT CODED. PATIENT WAS PLACED IN SUPINE POSITION BY REQUEST FROM THE ANESTHESIOLOGIST. PATIENT BLED OUT. ASSISTING SURGEON WAS RETRACTING AT THIS POINT. HE COMMENTED THAT THE STAPLES WERE PRESENT BUT DID NOT SEEM TO BE IN B-FORM (NOT COMPLETELY CRIMPED). PATIENT DID HAVE ARTERIAL STENOSIS, IT IS UNKNOWN IF ANY BLOOD PRODUCTS WERE ADMINISTERED. NO AUTOPSY WILL BE PERFORMED. STAPLE FORMATION ON THE SPECIMEN SIDE WAS NOT REVIEWED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC NEPHRECTOMY PROCEDURE, EXCESSIVE BLEEDING WAS NOTICED AFTER THE SECOND FIRING OF DEVICE ACROSS THE RENAL ARTERY. A VASCULAR/ GENERAL SURGEON WAS CALLED IN AND THE CASE WAS CONVERTED TO OPEN. THE STAPLE LINE DID NOT SEEM TO BE COMPROMISED AND THE BLEEDING WAS CONTROLLED AND THE SURGEON ATTEMPTED TO CLOSE. AT THIS POINT, MORE BLEEDING WAS VISIBLE AND A TEAR WAS NOTICED IN THE RENAL ARTERY ABOUT A CENTIMETER ABOVE STAPLE LINE. THE PATIENT EXPIRED. DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** ETS FLEX45 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death