BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESOPHYX2 - LINK DESIGN - SHORT

    MDR report key: 2463142 · Received February 21, 2012

    Report

    Report Number
    3005473391-2012-00053
    Event Type
    Malfunction
    Date Received
    February 21, 2012
    Date of Event
    January 23, 2012
    Report Date
    January 23, 2012
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC
    Product Code
    ODE
    PMA / PMN Number
    K092400
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINDINGS: BASED ON THE PRODUCT AND ENGINEERING INVESTIGATION, NO MATERIAL OR PROCESS DEFECT WAS FOUND. THE CENTER PIN ON THE HELIX BROKE BECAUSE OF A DUCTILE FAILURE CAUSED BY TORSIONAL OVERLOAD. DURING RETRACTOR RETRIEVAL, A SIGNIFICANT TORSIONAL LOAD WAS APPLIED TO THE CENTERING NEEDLE FROM TWISTING AND DISTORTING THE HELIX. THERE WAS NO LATENT DEFECT PRECIPITATING THE FAILURE. ALTHOUGH THERE WAS NO INDICATION OF AN INJURY TO THE PATIENT OR A MANUFACTURING PROCESS OR MATERIALS ISSUE, THIS FAILURE MODE IS BEING REPORTED DUE TO ESTABLISHING IF THIS MALFUNCTION WERE TO REOCCUR, A SERIOUS INJURY MAY OCCUR.

    Description of Event or Problem · 1

    TOWARDS THE END OF A SUCCESSFUL TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE, THE CENTER PIN OF THE HELIX WAS BENT OUTSIDE THE HELICAL COIL. BECAUSE OF THIS, THE SURGEON EXPERIENCED DIFFICULTY RETRACTING THE HELIX BACK INTO THE TISSUE MOLD. AFTER MANY FAILED FORCEFUL ATTEMPTS TO RETRACT THE HELIX, THE CENTER PIN FINALLY BROKE AND ADHERED TO THE SURFACE OF THE TISSUE MOLD. IN AN ATTEMPT TO RETRIEVE THE PIN WITH A GRASPER, THE PIN WAS INADVERTENTLY BUMPED AND THE PIN DROPPED INTO THE STOMACH. SUCTION WAS USED TO RETRIEVE THE PIN, THOUGH VISUAL CONFIRMATION OF THE RECOVERY COULD NOT BE VERIFIED. AS A PRECAUTION, AN X-RAY WAS TAKEN OF THE GENERAL AREA WITH NO EVIDENCE THE CENTER PIN REMAINED IN THE PATIENT, SO THE SURGEON'S ASSESSMENT WAS THE PIN WAS SUCCESSFULLY SUCTIONED OUT. THERE WERE NO PATIENT ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESOPHYX2 - LINK DESIGN - SHORT ODE ODE ENDOGASTRIC SOLUTIONS, INC R2002 401159

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR