BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM

    MDR report key: 22912405 · Received August 28, 2025

    Report

    Report Number
    3005099803-2025-04257
    Event Type
    Malfunction
    Date Received
    August 28, 2025
    Date of Event
    August 5, 2025
    Report Date
    August 28, 2025
    Manufacturer
    APOLLO ENDOSURGERY
    Product Code
    OCW
    PMA / PMN Number
    K231553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6. DEVICE CODE A150205 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF DEVICE DIFFICULT TO ADVANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH NXT WAS USED DURING AN EDGE PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO PASS THE DEVICE DOWN THE PATIENT'S ESOPHAGUS. THE PHYSICIAN ATTEMPTED A JAW THRUST BUT WAS STILL UNSUCCESSFUL. AS A RESULT, THE PHYSICIAN DECIDED TO SWITCH TO A NON-BSC DEVICE (OVERSCO) TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2742784 OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW APOLLO ENDOSURGERY UNK-P-OVERSTITCH_NXT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown