BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VLOCK 180 RELOAD

    MDR report key: 21459768 · Received February 25, 2025

    Report

    Report Number
    MW5166788
    Event Type
    Malfunction
    Date Received
    February 25, 2025
    Date of Event
    February 19, 2025
    Report Date
    February 21, 2025
    Manufacturer
    COVIDIEN
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AFTER USING ENDO STICH AND VLOCK 180 RELOAD TO CLOSE VAGINAL CUFF, THE DEVICE WAS REMOVED FROM THE SURGICAL FIELD. TEAM MEMBER OPENED THE DEVICE TO REMOVE THE NEEDLE FROM THE ENDO STITCH. ONCE OPENED AND UPON REMOVAL THE NEEDLE BROKE IN HALF. ALL PIECES OF THE DEVICE WERE LOCATED. DEVICE WAS TESTED BY SCRUB TECH AND SURGEON WITH NO CONCERNS PRIOR TO USE. THERE WAS NO HARM TO THE PATIENT. VLOC -REF-- VLOCA008L LOT-- N4L1458Y; ENDO STITCH DEVICE- REF--173016 LOT-- J4K3870EY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1326964 VLOCK 180 RELOAD SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM COVIDIEN N4L1458Y

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Other