BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESOPHYX2 - LINK DESIGN

    MDR report key: 2133602 · Received June 16, 2011

    Report

    Report Number
    3005473391-2011-00038
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    REDMOND
    Product Code
    ODE
    PMA / PMN Number
    K092400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - THE DEVICE WAS DISPOSED OF PER THE HOSPITAL'S STANDARD OPERATING PROCEDURE AND IS NOT AVAILABLE FOR EVAL.

    Description of Event or Problem · 1

    THE COMPANY REPRESENTATIVE, PRESENT AT TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE REPORTED THE PHYSICIAN NOTICED AN ESOPHAGEAL LACERATION OR PERFORATION AT ABOUT A 15CM DEPTH INTO THE ESOPHAGUS. THIS WAS NOTICED UPON REMOVAL OF THE DEVICE AFTER A SUCCESSFUL PROCEDURE. DURING THE INTRODUCTION PROCESS, THE PHYSICIAN DID NOT PERFORM AN ESOPHAGEAL DILATION, AS THE PHYSICIAN BELIEVED THE DEVICE WOULD PASS WITHOUT IT. THE PHYSICIAN ALSO BELIEVES THE CERVICAL ESOPHAGEAL LACERATION OCCURRED DURING THE DEVICE INTRODUCTION. THE PT WAS TREATED WITH RESOLUTION CLIP TO APPROXIMATE MUCOSAL EDGES, NPO, TPN. THE PT WAS EVALUATED WITH AN ESOPHAGRAM AND CT AND DISCHARGED TWO WEEKS LATER AND IS WITHOUT FURTHER SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESOPHYX2 - LINK DESIGN ODE REDMOND R2001 400980

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R