BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA II 60-3.5 SULU

    MDR report key: 3925991 · Received June 30, 2014

    Report

    Report Number
    2647580-2014-00486
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 6, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GDW
    PMA / PMN Number
    K900129
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: GASTRIC BYPASS. ACCORDING TO THE REPORTER: DURING BY-PASS, TIGHTNESS/SEALING TESTS WERE PERFORMED WITH AIR AND BLUE TINT. A SECOND TEST WITH BLUE TINT WAS PERFORMED AND ALL THE TESTS WERE NEGATIVE. LATER IN THE EVENING THE PATIENT HAD SEVERE PAIN, TACHYCARDIA AND BREATHING DIFFICULTIES. THE PATIENT HAD TO BE RE-OPERATED (OPEN SURGERY) DURING THE NIGHT TO FIND THE CAUSE OF THOSE SYMPTOMS. DURING ANOTHER TEST WITH BLUE TINT, THE SURGEON NOTICED A LEAKAGE IN THE MIDDLE OF STAPLE LINE AT THE STOMACH SITE. THE SURGEON MANUALLY OVERSEW THE LINE. ANOTHER TEST WITH BLUE TINT WAS PERFORMED WITH NEGATIVE RESULTS. THE PATIENT IS FINE. NO REINFORCEMENT MATERIAL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378659 ENDO GIA II 60-3.5 SULU REUSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC P4A0029X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EGIA ULTRA UNIVERSAL XL STAPLER, EGIAUXL,| LOT # P4A0633X, MANUFACTURE DATE: 01/2014,| EXP DATE: 01/31/2019, (B)(4)