BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-CLOSE KIT

    MDR report key: 22282728 · Received June 18, 2025

    Report

    Report Number
    22282728
    Event Type
    Malfunction
    Date Received
    June 18, 2025
    Date of Event
    June 9, 2025
    Report Date
    June 12, 2025
    Manufacturer
    NEW WAVE ENDO-SURGERY INC.
    Product Code
    HCF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN THE M-CLOSE DEVICE WAS ENGAGED, THE NEEDLES WOULD NOT RETRACT WHEN THE WHITE BUTTON WAS PUSHED (AS PER PROTOCOL). THE VICRYL TIE USED WITH THE DEVICE WAS CUT OUT AND PULLED OUT OF THE DEVICE IN AN ATTEMPT TO GET THE NEEDLES TO RETRACT, BUT THAT DID NOT WORK. THE PROVIDER WAS ABLE TO PULL THE M-CLOSE DEVICE OUT OF THE INCISION SITE WITHOUT HARM TO THE PATIENT. THE DEVICE WAS REMOVED FROM USE AND THE SURGICAL FIELD AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1767528 M-CLOSE KIT INSTRUMENT, LIGATURE PASSING AND KNOT TYING HCF NEW WAVE ENDO-SURGERY INC. 27-101 E1325

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female