BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-CLOSE KIT

    MDR report key: 22814542 · Received August 15, 2025

    Report

    Report Number
    22814542
    Event Type
    Malfunction
    Date Received
    August 15, 2025
    Date of Event
    July 31, 2025
    Report Date
    August 7, 2025
    Manufacturer
    NEW WAVE ENDO
    Product Code
    HCF
    UDI-DI
    00850009417053
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE DEVICE WOULD NOT COMPLETE THE SECOND CLICK TO COMPLETE THE CLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180253 M-CLOSE KIT INSTRUMENT, LIGATURE PASSING AND KNOT TYING HCF NEW WAVE ENDO 27-101 B0725 00850009417053

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male