BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-CLOSE KIT

    MDR report key: 17540044 · Received August 14, 2023

    Report

    Report Number
    17540044
    Event Type
    Malfunction
    Date Received
    August 14, 2023
    Date of Event
    May 10, 2023
    Report Date
    May 11, 2023
    Manufacturer
    NEW WAVE ENDO
    Product Code
    HCF
    UDI-DI
    00850009417022
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    M-CLOSE DEVICE NOT FIRING PROPERLY WHEN INSERTED INTO PATIENT. SURGEON INSERTED M-CLOSE DEVICE, ATTEMPTED TO DEPLOY, HOWEVER M-CLOSE DEVICE WAS DEFECTIVE. NO HARM DONE TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215032 M-CLOSE KIT INSTRUMENT, LIGATURE PASSING AND KNOT TYING HCF NEW WAVE ENDO 27-101 C1523 00850009417022

    Patients

    Seq Age Sex Outcome Treatment
    1 16425 DA Female