BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOPHYX2 - LINK DESIGN

    MDR report key: 2588704 · Received May 25, 2012

    Report

    Report Number
    3005473391-2012-00062
    Event Type
    Injury
    Date Received
    May 25, 2012
    Date of Event
    December 19, 2011
    Report Date
    April 26, 2012
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC
    Product Code
    ODE
    PMA / PMN Number
    K092400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    TWO DAYS FOLLOWING A SUCCESSFUL TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE, THE PATIENT BEGAN TO EXPERIENCE SYMPTOMS OF PAIN, BLOATING AND TACHYCARDIA. THE PHYSICIAN PERFORMED LAPAROSCOPIC DRAINAGE DUE TO A PERFORATION AND PLACED AN ESOPHAGEAL STENT. AFTER APPROXIMATELY 3 WEEKS IN THE HOSPITAL, THE PATIENT HAS SINCE GONE HOME AND IS REPORTED AS DOING FINE. INITIALLY, THE PHYSICIAN FELT THAT THE PERFORATION OCCURRED DURING THE LAPAROSCOPIC PROCEDURE SHE PERFORMED BEFORE DOING THE TIF PROCEDURE BUT SHE HAS SINCE SAID THAT SHE IS UNCERTAIN OF WHEN THE PERFORATION ACTUALLY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESOPHYX2 - LINK DESIGN ODE ODE ENDOGASTRIC SOLUTIONS, INC R2001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R