BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVERSTITCH SX ENDOSCOPIC SUTURE SYSTEM

    MDR report key: 23508487 · Received November 10, 2025

    Report

    Report Number
    3005099803-2025-05752
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    October 11, 2025
    Report Date
    November 10, 2025
    Manufacturer
    APOLLO ENDOSURGERY
    Product Code
    OCW
    UDI-DI
    20811955020715
    PMA / PMN Number
    K210266
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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 THAT AN OVERSTITCH SX ENDOSCOPIC SUTURE SYSTEM WAS TO BE USED DURING AN ESG PROCEDURE ON (B)(6) 2025. BEFORE THE PROCEDURE BEGAN, THE NEEDLE SHAFT OF THE OVERSTITCH WAS BENT AND WOULD NOT ALIGN TO THE ANCHOR EXCHANGE CATHETER. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A NEW OVERSTITCH NXT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181552 OVERSTITCH SX ENDOSCOPIC SUTURE SYSTEM ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW APOLLO ENDOSURGERY ESS-G02-SX1 2024020002 20811955020715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown