BEUDAMED
    FDA Adverse Event Death Summary report: N

    PWRD ECH FLEX 45MM 28CM SHAFT

    MDR report key: 3771155 · Received April 24, 2014

    Report

    Report Number
    3005075853-2014-02801
    Event Type
    Death
    Date Received
    April 24, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 3, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY CONTACT.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION REQUESTED AND OBTAINED: WAS THERE A PROXIMAL OR DISTAL CONTROL PRIOR TO FIRING? NO. WAS DONE TO CONTROL THE BLEEDING PRIOR TO FIRING THE DEVICE? OR THE DID THE DEVICE CLOSURE CONTROL THE BLEEDING? PRIOR TO FIRING, THE SURGEON WAS EXPECT THAT THE BLEEDING WAS STOPPED IF THE DEVICE WAS FIRED. FURTHER DETAILED INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. WHAT IS A TACO SEAL? TACO SEAL IS A KIND OF HEMOSTATIC MATERIAL. WHAT WERE THE PATIENT'S PREVIOUS SURGERY? RIGHT UPPER LOBECTOMY AND AN UNKNOWN LUNG SURGERY. IS THE DEVICE AVAILABLE FOR RETURNED? NO. DID THE PATIENT HAVE ANY PRE-EXISTING CONDITION THAT WOULD HAVE IMPACTED THE OUTCOME OF THE PROCEDURE? THE INFORMATION WAS NOT PROVIDED FROM THE HOSPITAL. WHAT WAS THE INDICATION FOR SURGERY? ANY OTHER LUNG CONDITIONS PRESENT PRIOR TO SURGERY? RECURRENT LUNG CANCER. IS THE SURGEON WILLING TO SPEAK TO AN EES DIRECTOR? NO. WERE ANY CLIPS USED IN THE PROCEDURE BEFORE OR AFTER THIS EVENT? BEFORE THE EVENT, NO CLIP WERE USED, BUT IT WAS UNKNOWN AFTER THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC LEFT UPPER LOBECTOMY PROCEDURE, THE DEVICE LOADING A GRAY CARTRIDGE WAS USED ON THE PULMONARY VEIN AT THE 1ST FIRING. AT THE 2ND AND THE 3RD FIRING, IT WAS USED ON THE UPPER AND LOWER INTERLOBAR WITH GOLD CARTRIDGES. AT THE 4TH FIRING, IT WAS USED ON THE BRONCHIAL TUBES WITH A GOLD CARTRIDGE. THE DEVICE FUNCTIONED AS INTENDED AND THERE WAS NO PROBLEM. AT THE 5TH FIRING, BLEEDING OCCURRED WHILE THE DEVICE LOADING A WHITE CARTRIDGE WAS APPROACHING THE PULMONARY ARTERY. AT THE TIME, ALTHOUGH THE ARTERY WAS BETWEEN THE JAWS, THE JAWS WERE NOT BEING CLOSED. SOON AFTER THE BLEEDING WAS NOTICED, THE JAWS WERE CLOSED AND THE DEVICE WAS FIRED. THE FORMATION OF STAPLES COULD NOT BE CHECKED BECAUSE OF BLEEDING. THE BLEEDING DID NOT STOP, SO ASTRICTION WAS PERFORMED WITH A COTTON AND A TACO SEAL WAS USED. THE SPECIMEN WAS RETRIEVED. THE SURGEON IDENTIFIED THE BLEEDING POINT, BUT THE BLEEDING CONTINUED WHEN ASTRICTION WAS STOPPED. THE OPERATION WAS CONVERTED TO OPEN. BLOOD TRANSFUSION AND ASTRICTION WITH A FINGER WERE PERFORMED AT A TIME. SUDDENLY, THE BLOOD PRESSURE SHARPLY DROPPED AND THE PATIENT WENT INTO CARDIAC ARREST. A CARDIOVASCULAR SURGEON HELPED AND AN ARTIFICIAL HEART LUNG WAS USED, BUT THE PATIENT DIED. THE AMOUNT OF BLEEDING WAS MORE THAN 10000CC. THE PATIENT HAD LUNG PROCEDURES BEFORE AND SURROUNDING TISSUES WERE ADHERING. NO DEVICE WILL BE RETURNING. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NO RESPONSE HAS BEEN RECEIVED TO DATE, A SUPPLEMENTAL REPORT WILL BE SENT UPON RECEIPT OF ADDITIONAL INFORMATION. SATIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250164 PWRD ECH FLEX 45MM 28CM SHAFT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK L4E183

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death| R RELOAD ECR45W