BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEW WAVE ENDO M-CLOSE PORT CLOSURE KIT

    MDR report key: 23149119 · Received September 25, 2025

    Report

    Report Number
    MW5176622
    Event Type
    Malfunction
    Date Received
    September 25, 2025
    Date of Event
    May 8, 2025
    Report Date
    September 22, 2025
    Manufacturer
    NEW WAVE ENDO
    Product Code
    HCF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    M-CLOSE KIT OPENED TO THE STERILE FIELD FOR GASTRECTOMY SLEEVE. THE GUIDE WIRE INCLUDED IN THE KIT WAS KINKED AND WOULD NOT BE ABLE TO ENTER THE M-CLOSE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302928 NEW WAVE ENDO M-CLOSE PORT CLOSURE KIT INSTRUMENT, LIGATURE PASSING AND KNOT TYING HCF NEW WAVE ENDO REF 27-101 C2525

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female