BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERED PLUS STANDARD 45

    MDR report key: 12866453 · Received November 23, 2021

    Report

    Report Number
    3005075853-2021-07162
    Event Type
    Death
    Date Received
    November 23, 2021
    Date of Event
    October 4, 2021
    Report Date
    November 23, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036015352
    PMA / PMN Number
    K163454
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 11/23/2021. BATCH # UNK. INVESTIGATION SUMMARY: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AS PART OF ETHICON'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO [NON-CONFORMANCES / MANUFACTURING IRREGULARITIES] WERE IDENTIFIED. ADDITIONAL INFORMATION RECEIVED: THE SURGEON TOLD THE REPRESENTATIVE THAT THE PATIENT THAT WAS READMITTED TO THE HOSPITAL IN SHOCK THE THIRD DAY AFTER A GASTRIC BY-PASS. THE AUTOPSY SHOWED A GASTRO-JEJUNUM ANASTOMOSIS LEAK WITH 6 LITERS OF INTRA-ABDOMINAL LIQUID. SURGEON SAID THAT HE HAD ANY PROBLEM IN THE SURGERY AND THE LEAK TEST WAS OK, SO HE HAD NO EXPLANATION FOR THIS CASE. THE PRODUCTS ASSOCIATED WITH THIS CASE WERE PSEE45A, GST45B, GST45W. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT WAS THE PATIENT¿S BMI AND GENDER? BMI OVER 35 AND MALE. WAS THE PROCEDURE PERFORMED FOR WEIGHT LOSS? YES. ANY DIFFICULTY WITH DEVICE IN INITIAL PROCEDURE? NO. ANY ISSUE NOTED WITH STAPLE FORMATION? NO. WHAT COLOR CARTRIDGE WERE USED THROUGHOUT THE PROCEDURE? BLUE AND WHITE (45 MM). HOW WAS THE GASTRO-JEJUNUM CREATED ON THE PATIENT, (WITH LINEAR STAPLER, CIRCULAR STAPLER OR HAND SEWN)? WITH GST45B. WHAT IS THE TIMELINE OF EVENT? DON´T UNDERSTAND THE QUESTION. AUTOPSY AVAILABLE? NO. WHAT WAS CAUSE OF DEATH? GASTRO-JEJUNUM LEAK. IS THE SURGEON INTERESTED IN SPEAKING WITH ETHICON MEDICAL? NO. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THREE DAYS AFTER A ROUX-EN-Y PROCEDURE THE PATIENT DIED. THERE WAS A GASTROYEYUNO ANASTOMOSIS LEAK. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? YES. PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? PERITONITIS AND DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1762763 POWERED PLUS STANDARD 45 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. PSEE45A V95K9Z 10705036015352

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death GST45B X2| GST45W X3