BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVERSTITCH SX ENDOSCOPIC SUTURE SYSTEM

    MDR report key: 24059947 · Received January 13, 2026

    Report

    Report Number
    3005099803-2026-00192
    Event Type
    Malfunction
    Date Received
    January 13, 2026
    Date of Event
    December 16, 2025
    Report Date
    January 13, 2026
    Manufacturer
    APOLLO ENDOSURGERY
    Product Code
    OCW
    UDI-DI
    20811955020715
    PMA / PMN Number
    K210266
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: DEVICE CODE A040609 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF NEEDLE SHAFT BENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OVERSTITCH NXT ENDOSCOPIC SUTURING SYSTEM WAS USED DURING AN ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS DIFFICULT TO OPEN AND CLOSE THE NEEDLE SHAFT, AND THE NEEDLE SHAFT BENT. THE PROCEDURE WAS COMPLETED WITH A NEW OVERSTITCH NXT. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121118 OVERSTITCH SX ENDOSCOPIC SUTURE SYSTEM ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW APOLLO ENDOSURGERY ESS-G02-SX1 2024110181 20811955020715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown