BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOCLIP

    MDR report key: 4156024 · Received October 3, 2014

    Report

    Report Number
    MW5038539
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    August 22, 2014
    Report Date
    October 3, 2014
    Manufacturer
    COVIDIEN
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT A LAP CHOLE AND 3 CLIPS WERE PLACED USING A COVIDIEN ENDOCLIP III 1-USE 5 MM W/CLIPLOGIC TECH "TIT" CLIP AND SUBSEQUENTLY EXPERIENCED A BILE LEAK REQUIRING PROLONGED HOSPITALIZATION. PATIENT HAD HIDA SCAN AND ERCP WITH STENT PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617513 ENDOCLIP ENDOCLIP FZP COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization