BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOPHYX2 - LINK DESIGN - SHORT

    MDR report key: 3782031 · Received April 30, 2014

    Report

    Report Number
    3005473391-2014-00089
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 31, 2014
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC
    Product Code
    ODE
    PMA / PMN Number
    K092400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO ALLEGATION OF PRODUCT MALFUNCTION AND THE DEVICE WAS DISPOSED OF PER THE HOSPITAL'S STANDARD OPERATING PROCEDURE AND IS NOT AVAILABLE FOR AN EVALUATION.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE. AFTER THE 1 O'CLOCK POSITION OF THE VALVE WAS BUILT, THERE WAS A LOT OF BLOOD. ONCE THE BLOOD WAS SUCTIONED AWAY, A MUCOSAL TEAR WAS NOTICED. ONCE THE SURGEON FINISHED THE 5 O'CLOCK AND 7 O'CLOCK POSITIONS, THE TEAR WAS CHECK LAPAROSCOPICALLY WHICH DIDN'T REVEAL ANYTHING AND NO LEAKS WERE NOTED. A FEW SUTURES WERE PLACED AS A PRECAUTION TO CLOSE THE TEAR AND A DRAIN WAS PLACED. THE SURGEON THEN PERFORMED A SWALLOW STUDY WHICH SHOWED NO LEAKS, SO THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT IS TO FOLLOW UP WITH THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260883 ESOPHYX2 - LINK DESIGN - SHORT ODE ODE ENDOGASTRIC SOLUTIONS, INC R2002

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R