BEUDAMED
    FDA Adverse Event Death Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3775617 · Received April 28, 2014

    Report

    Report Number
    3005075853-2014-02873
    Event Type
    Death
    Date Received
    April 28, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 14, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED FOR EVALUATION. THE MANUFACTURING RECORDS WERE REVIEWED FOR THE LOT NUMBER PROVIDED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    DURING A CALL WITH THE SURGEON ON (B)(6) 2014, THE SURGEON STATED THAT DURING THE GASTRIC SLEEVE PROCEDURE, HE MOBILIZES THE STOMACH. HE USES THE GREEN RELOAD FOR THE FIRST FIRING ON THE STOMACH AND USES GOLD RELOADS FOR SUBSEQUENT FIRINGS. HE OVERSEWS THE STAPLE LINES WITH PDS SUTURE USING INVAGINATION AND CONTINUOUS SUTURE TECHNIQUE. LASTLY, HE CHECKS THE STAPLE LINE FOR HEMOSTASIS/PNEUMOSTASIS USING A METHYLENE BLUE. THERE WAS NO LEAK DETECTED. HE ALSO USES A COLLAGEN HEMOSTAT AFTER STAPLING AND SUTURE. THERE WERE NO ISSUES WITH THE DEVICE DURING THE INITIAL PROCEDURE. EVERYTHING WENT WELL. THE PATIENT RETURNED TO SURGEON¿S OFFICE APPROXIMATELY 7-9 DAYS POST OPERATIVELY WITH NAUSEA, VOMITING AND FEBRILE. A CT SCAN WAS PERFORMED AND A LEAK WAS DETECTED. THE PATIENT WAS TAKEN BACK TO SURGERY ON (B)(6) 2014. THE STAPLE LINE FAILURE APPEARS TO BE NEAR THE CARDIA. THE STAPLE FORMATION WAS DIFFICULT TO SEE AS THE AREA WAS INFLAMED. STAPLES APPEARED TO BE SEPARATED, BUT THE SUTURES WERE HOLDING. THE DEFECT WAS CLOSED AND A GASTRIC TUBE WAS PLACED. THE PATIENT SUBSEQUENTLY DIES. THE SURGEON STATES THE PRELIMINARY CAUSE OF DEATH IS RESPIRATORY FAILURE AND IS NOT RELATED TO THE DEVICE. THE AUTOPSY REPORT IS PENDING. HOWEVER, TO OBTAIN A COPY OF THE REPORT, GOVERNMENT PERMISSION WILL NEED TO BE GRANTED. AS PER THE HOSPITAL ADMINISTRATOR ON (B)(6) 2014, THE PATIENT HAD NO PRE-EXISTING RESPIRATION DISEASE: COPD, ASTHMA OR OTHERS. THE PATIENT DEVELOPED A RESPIRATORY INFECTION POST RE-INTERVENTION, DEATH DUE TO ACUTE RESPIRATORY INSUFFICIENCY. IT IS UNCLEAR AS TO CAUSE OF DEATH. THE HOSPITAL DOES NOT HAVE ACCESS TO AUTOPSY REPORT AS IT WAS PERFORMED OUT OF THE HOSPITAL UNDER LEGAL REQUIREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254914 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4DP53

    Patients

    Seq Age Sex Outcome Treatment
    1 Death RELOAD ECR60D, ECR60G