BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICLIP III APPLIER

    MDR report key: 16371018 · Received February 13, 2023

    Report

    Report Number
    MW5114895
    Event Type
    Malfunction
    Date Received
    February 13, 2023
    Date of Event
    February 7, 2023
    Report Date
    February 8, 2023
    Manufacturer
    COVIDIEN
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    COVIDIEN PREMIUM SURGICLIP III CLIP APPLIER (9.0" SMALL). REFERENCE 133650, LOT P2M0004, EXP 2027-11-30; CONTINUOUSLY MISFIRING THROUGHOUT CRITICAL TIMES. THIS HAPPENED WITH 2 PTS SAME DAY. REF REPORT: MW5114896.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607550 SURGICLIP III APPLIER CLIP, IMPLANTABLE FZP COVIDIEN P2M004

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown