BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CLIP III

    MDR report key: 3840242 · Received April 30, 2014

    Report

    Report Number
    3840242
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    September 4, 2013
    Report Date
    February 27, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ENDO CLIP III CLIP APPLIER WAS USED TO CLIP CYSTIC DUCT. IT FIRED THE FIRST TIME, BUT JAMMED WHEN FIRED A SECOND TIME. IT IS UNKNOWN IF THERE WAS TISSUE ATTACHED WHEN THE SECOND ATTEMPT AT FIRING OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258036 ENDO CLIP III CLIP, IMPLANTABLE GDO COVIDIEN * N3G0411MX

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR