BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CLIP III

    MDR report key: 2771346 · Received September 21, 2012

    Report

    Report Number
    2771346
    Event Type
    Malfunction
    Date Received
    September 21, 2012
    Date of Event
    August 22, 2012
    Report Date
    September 21, 2012
    Manufacturer
    COVIDIEN
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE SURGEON NOTED THE DEVICE WAS NOT FIRING IMMEDIATELY; INSTEAD IT HAD A TWO OR THREE SECOND DELAY AND THE CLIPS WERE ALSO NOTED TO BE LOOSE. A SECOND DEVICE WAS USED AND WORKED WITHOUT INCIDENT. IT IS UNKNOWN IF THE SECOND DEVICE WAS OF THE SAME OR DIFFERENT LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO CLIP III CLIP APPLIER FZP COVIDIEN * N2F0240X

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR