BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM

    MDR report key: 19286510 · Received May 10, 2024

    Report

    Report Number
    3005099803-2024-02060
    Event Type
    Malfunction
    Date Received
    May 10, 2024
    Date of Event
    April 15, 2024
    Report Date
    May 10, 2024
    Manufacturer
    APOLLO ENDOSURGERY
    Product Code
    OCW
    UDI-DI
    10811955020893
    PMA / PMN Number
    K231553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: DEVICE CODE A1702 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF DEVICE-DEVICE INCOMPATIBLE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ON APRIL 16, 2024 THAT THE OVERTUBE AND NXT SYSTEM WOULD NOT FIT TOGETHER. ON (B)(6) 2024 THE PHYSICIAN REPORT WHEN TRYING TO INTUBATE WITH THE SCOPE AFTER RE-TAPING THE DEVICE TO THE SCOPE AND ADDING ADDITIONAL LUBRICATION, THAT THE SCOPE AND NXT WOULD NOT FIT THROUGH THE OVERTUBE. THE PHYSICIAN TRIED MULTIPLE ATTEMPTS. THE PHYSICIAN REMOVED THE OVERTUBE AND THE PROCEDURE WAS COMPLETED WITH THE NXT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2122927 OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW APOLLO ENDOSURGERY ESS-G02-NXT 10811955020893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown