BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM

    MDR report key: 22327711 · Received June 25, 2025

    Report

    Report Number
    3005099803-2025-02922
    Event Type
    Injury
    Date Received
    June 25, 2025
    Date of Event
    May 30, 2025
    Report Date
    July 21, 2025
    Manufacturer
    APOLLO ENDOSURGERY
    Product Code
    OCW
    UDI-DI
    10811955020893
    PMA / PMN Number
    K231553
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF CODE F23 CAPTURES THE REPORTABLE EVENT OF UNEXPECTED MEDICAL INTERVENTION. IMDRF CODE A150208 CAPTURES THE REPORTABLE EVENT OF NEEDLE SHAFT STUCK.

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF CODE F23 CAPTURES THE REPORTABLE EVENT OF UNEXPECTED MEDICAL INTERVENTION. IMDRF CODE A150208 CAPTURES THE REPORTABLE EVENT OF NEEDLE SHAFT STUCK. CORRECTION: B5: DESCRIBE EVENT OR PROBLEM. H6: DEVICE CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN OVERSTITCH NXT WAS USED TO TREAT CANCER IN THE ESOPHAGUS DURING A STENT FIXATION PROCEDURE. DURING THE PROCEDURE, THE OVERSTITCH NXT TOWER GOT STUCK ON STENT. THE SUTURES WERE CUT, AND THE DEVICE WAS SLOWLY DISLODGED FROM THE STENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OVERSTITCH NXT AND AGILE STENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN OVERSTITCH NXT WAS USED TO TREAT CANCER IN THE ESOPHAGUS DURING A STENT FIXATION PROCEDURE. DURING THE PROCEDURE, THE OVERSTITCH NXT TOWER GOT STUCK ON STENT. THE SUTURES WERE CUT, AND THE DEVICE WAS SLOWLY DISLODGED FROM THE STENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OVERSTITCH NXT AND AGILE STENT. NOTE: THE INSTRUCTIONS FOR USE (IFU) INDICATE THAT STENT FIXATION IS NOT ON LABEL IN THE US AND THE LABELING STATES THE DEVICE IS NOT FOR USE WITH MALIGNANT TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2361048 OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW APOLLO ENDOSURGERY ESS-ESG-NXT 10811955020893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention