BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-CLOSE KIT

    MDR report key: 24442245 · Received February 25, 2026

    Report

    Report Number
    24442245
    Event Type
    Malfunction
    Date Received
    February 25, 2026
    Date of Event
    January 5, 2026
    Report Date
    February 16, 2026
    Manufacturer
    NEW WAVE ENDO
    Product Code
    HCF
    UDI-DI
    00850009417022
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    WHILE USING THE M-CLOSE DEVICE, IT WAS NOTICED THAT PART OF IT, SPECIFICALLY THE LOOP WIRE, WAS MISSING. CT AND X-RAY WERE COMPLETED ON THE PATIENT, NEGATIVE FOR FOREIGN BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502908 M-CLOSE KIT INSTRUMENT, LIGATURE PASSING AND KNOT TYING HCF NEW WAVE ENDO 27-101 A0926 00850009417022

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Male Other