BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILS 25MM, CURVED

    MDR report key: 8077195 · Received November 16, 2018

    Report

    Report Number
    3005075853-2018-14392
    Event Type
    Injury
    Date Received
    November 16, 2018
    Date of Event
    October 24, 2018
    Report Date
    October 29, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036003458
    PMA / PMN Number
    K983536
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SPECIFIC LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT WAS THE SURGEON¿S EXPERIENCE WITH THE CIRCULAR STAPLER? NO INFORMATION. INTRAOPERATIVELY, DID THE SURGEON RECEIVE AUDIBLE OR VISUAL CONFIRMATION THAT THE WASHER WAS CUT? NO. NO BREAKING SOUND OF THE WASHER WAS HEARD AT THE FIRING. WERE THERE ANY ISSUES NOTED WITH STAPLE FORMATION AT ANY POINT THROUGHOUT THE CARE OF THE PATIENT? DURING THE INITIAL OPERATION, DR. COMMENTED THERE WAS NO PROBLEM WITH THE STAPLE FORMATION, BUT THE DETAILED OF STAPLE FORMATION WAS NOT FOUND BECAUSE THE ANASTOMOSIS SITE WAS NOT OBSERVED FROM THE INNER SITE. HOW LONG AFTER THE PROCEDURE WERE SIGNS OF A LEAK OBSERVED? FOUR DAYS AFTER THE PROCEDURE. THE LEAK WAS CONFIRMED FROM THE DRAIN NEAR THE ANASTOMOSIS SITE. WHAT SYMPTOMS DID THE PATIENT PRESENT? THE PATIENT SUFFERED FROM THE LEAK AND SHOCK. AFTER A WHILE, THE RE-OPERATION WAS PERFORMED BECAUSE OF ABDOMINAL COMPARTMENT SYNDROME. THE DRAIN WAS SET AGAIN IN THE RE-OPERATION. AFTER THE RE-OPERATION, THE PATIENT IS BRAIN-DEAD. HOW WAS THE LEAK ADDRESSED? NO INFORMATION. SEE THE ABOVE ABOUT RE-OPERATION. WHAT IS THE CURRENT PATIENT STATUS? NO INFORMATION FROM THE HOSPITAL. DR. COMMENTED THE PATIENT HAD DIABETES, HIGH-BLOOD PRESSURE AND WITH DIMINISHED RENAL FUNCTION. DR. DIDN'T KNOW THE CAUSAL CONNECTION OF SHOCK AND LEAK. THE PATIENT'S MATTER MAY CAUSED THIS EVENT, BUT DR. THOUGHT THE LEAK MAY BE ONE OF THE CAUSE OF THIS EVENT, TOO.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT 4 DAYS AFTER AN OPEN TOTAL GASTRECTOMY ON (B)(6) 2018, LEAKAGE OCCURRED. THE PATIENT SUFFERED FROM SHOCK AND IS BRAIN-DEAD. THE DEVICE WAS USED FOR END TO SIDE ANASTOMOSIS BETWEEN THE ESOPHAGUS AND THE JEJUNUM. THE ANVIL WAS SET AT THE SIDE OF THE ESOPHAGUS. NO BREAKING SOUND OF THE WASHER WAS HEARD AT THE FIRING. WHEN A LEAK TEST WAS PERFORMED, AIR LEAKAGE WAS OBSERVED, SO ADDITIONAL HAND SUTURE WAS PERFORMED WITH A NEEDLE-SUTURE. AFTER THAT, THE INCISION WAS CLOSED SINCE NO LEAKAGE WAS OBSERVED WHEN A LEAK TEST WAS PERFORMED AGAIN. THE SURGEON WHO DID NOT FIRE THE DEVICE COMMENTED THAT THERE WAS A POSSIBILITY THAT THE STAPLES WERE UNFORMED AND THE INCOMPLETE STAPLING CAUSED THE LEAKAGE. BUT, IT WAS UNKNOWN THAT THE INCOMPLETE STAPLING CAUSED DIRECTLY THE SHOCK STATE OF THE PATIENT. THE SURGEON WHO FIRED THE DEVICE IN QUESTION WAS A DOCTOR OF ANOTHER HOSPITAL. THE PATIENT IS STILL BRAIN-DEAD AND HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918533 ILS 25MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036003458

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R| S