BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIUM SURGICLIP III

    MDR report key: 10476591 · Received September 1, 2020

    Report

    Report Number
    10476591
    Event Type
    Malfunction
    Date Received
    September 1, 2020
    Date of Event
    August 3, 2020
    Report Date
    August 12, 2020
    Manufacturer
    COVIDIEN
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PER MIDAS REPORT, THE CLIPS OF THE COVIDIEN LP PREMIUM SURGICLIP III CLIP APPLIER FAILED TO FULLY ENGAGE AND FELL OFF OR DID NOT FULLY SEAL VEINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940527 PREMIUM SURGICLIP III CLIP, IMPLANTABLE FZP COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 23360 DA