BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOPHYX2 - LINK DESIGN - SHORT

    MDR report key: 2471463 · Received February 28, 2012

    Report

    Report Number
    3005473391-2012-00056
    Event Type
    Injury
    Date Received
    February 28, 2012
    Date of Event
    December 23, 2011
    Report Date
    February 10, 2012
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC
    Product Code
    ODE
    PMA / PMN Number
    K092400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    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

    IN THE RECOVERY ROOM AFTER A SUCCESSFUL TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE, THE PATIENT VIOLENTLY WRETCHED. NO OTHER COMPLICATIONS OCCURRED AND THE PATIENT WAS RELEASED FROM THE HOSPITAL THE NEXT DAY PER NORMAL PROCEDURE. FOUR DAYS LATER, THE PATIENT WAS ADMITTED TO ANOTHER HOSPITAL WITH A LEFT PLEURAL EFFUSION. AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WAS PERFORMED AND A SMALL LEAK FROM ONE OF THE POSTERIOR FASTENERS WAS FOUND. IT WAS REPAIRED AND A CHEST TUBE WAS PLACED IN THE PATIENT. A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) WITH JEJUNOSTOMY WAS ALSO PLACED FOR FEEDING. THE DOCTOR BEGAN A DIET AND THE PATIENT WENT ON TO DO VERY WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESOPHYX2 - LINK DESIGN - SHORT ODE ODE ENDOGASTRIC SOLUTIONS, INC R2002 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R