BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICLIP

    MDR report key: 10477004 · Received September 1, 2020

    Report

    Report Number
    10477004
    Event Type
    Malfunction
    Date Received
    September 1, 2020
    Date of Event
    August 10, 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, A COVIDIEN LP SURGICLIP CLIP APPLIER MISFIRED AND TOOK ADDITIONAL ATTEMPT. SURGICLIP APPLIER WORKED AGAIN ON FOLLOWING APPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941834 SURGICLIP CLIP, IMPLANTABLE FZP COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 13505 DA