BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESOPHYX2 - LINK DESIGN - SHORT

    MDR report key: 2528196 · Received April 11, 2012

    Report

    Report Number
    3005473391-2012-00059
    Event Type
    Malfunction
    Date Received
    April 11, 2012
    Date of Event
    March 14, 2012
    Report Date
    March 14, 2012
    Manufacturer
    ENDOGASTRIC SOLUTIONS, INC
    Product Code
    ODE
    PMA / PMN Number
    K092400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT USED PER THE INSTRUCTIONS FOR USE (IFU). AS STATED IN THE "WARNINGS AND PRECAUTIONS" SECTION, "DO NOT USE EQUIPMENT OR ITEMS THAT ARE NOT PROPERLY FUNCTIONING." ALSO, IN SECTION "ENDOSCOPE INSERTION", IT IS STATED TO USE THE RED ENDOSCOPE RETAINER TOOL WHEN SECURING THE ENDOSCOPE TO THE DEVICE.

    Description of Event or Problem · 1

    BEFORE BEGINNING A TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) PROCEDURE AND BECAUSE OF A MISSING SCOPE LOOP INSTALLATION TOOL, THE PHYSICIAN DECIDED TO USE FORCEPS TO PULL THE ENDOSCOPE RETAINER BAND AROUND THE ENDOSCOPE. CONSEQUENTLY DURING THE PROCESS, THE BAND BROKE. THE PHYSICIAN THEN USED A SUTURE IN PLACE OF THE RETAINER BAND TO SECURE THE ENDOSCOPE TO THE DEVICE'S TISSUE MOLD AND PROCEEDED WITH THE PROCEDURE. ONCE THE DEVICE/ENDOSCOPE WAS IN THE STOMACH, THE ENDOSCOPE TIP WOULD NOT PASS BACK THROUGH THE SUTURE AS THE ENDOSCOPE WAS BEING DRAWN BACK TO BEGIN THE PROCEDURE. THE PHYSICIAN APPLIED FORCE IN AN ATTEMPT TO BREAK THE SUTURE AND DURING THIS PROCESS THE TIP OF THE PLASTIC TISSUE MOLD BECAME DETACHED FROM THE DEVICE. THE DEVICE WAS SAFELY EXTRACTED AND THE TISSUE MOLD TIP WAS RETRIEVED USING A SNARE AND ALSO REMOVED FROM THE STOMACH. A SECOND DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESOPHYX2 - LINK DESIGN - SHORT ODE ODE ENDOGASTRIC SOLUTIONS, INC R2002 401225

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention