BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVERSTITCH ENDOSCOPIC SUTURE SYSTEM

    MDR report key: 23513601 · Received November 10, 2025

    Report

    Report Number
    3005099803-2025-05793
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    October 12, 2025
    Report Date
    November 10, 2025
    Manufacturer
    APOLLO ENDOSURGERY
    Product Code
    OCW
    UDI-DI
    20811955020661
    PMA / PMN Number
    K181141
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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 ENDOSCOPIC SUTURE SYSTEM WAS USED DURING A PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN OBSERVED THAT THE NEEDLE SHAFT WAS BENT AND NOT ALIGNED. THE PROCEDURE WAS COMPLETED WITH A NEW OVERSTITCH DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1962696 OVERSTITCH ENDOSCOPIC SUTURE SYSTEM ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW APOLLO ENDOSURGERY ESS-G02-160 2024090286 20811955020661

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown