BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOPHYX2 -05

    MDR report key: 2471456 · Received February 28, 2012

    Report

    Report Number
    3005473391-2012-00055
    Event Type
    Injury
    Date Received
    February 28, 2012
    Date of Event
    April 27, 2011
    Report Date
    February 13, 2012
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC
    Product Code
    ODE
    PMA / PMN Number
    K092400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE THE ADVERSE PATIENT SYMPTOMS PRESENTED ITSELF SOMETIME AFTER THE PROCEDURE, THE DEVICE HAD ALREADY BEEN DISPOSED OF PER THE HOSPITAL'S STANDARD OPERATING PROCEDURE AND IS NOT AVAILABLE FOR AN EVALUATION.NO ALLEGATION OF PRODUCT MALFUNCTION.

    Description of Event or Problem · 1

    A 3-4 WEEKS POST A SUCCESSFUL TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE, IT WAS NOTED THAT THERE WAS CONTINUED PAIN IN THE PATIENTS SHOULDER. FIVE WEEKS POST OPERATION, THE PATIENT WAS TAKEN TO ANOTHER HOSPITAL WHERE SCANS REVEALED A MODERATE SIZED PERICARDIAL EFFUSION. THE PATIENT WAS TAKEN TO THE CARDIAC CATHETERIZATION LAB FOR PERIOCARDIOCENTESIS OF 470 MLS OF BLOODY FLUID. THE PATIENT IS REPORTED TO BE DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESOPHYX2 -05 ODE ODE ENDOGASTRIC SOLUTIONS, INC R2000 400650

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R