BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    (1) ENDO CLIP 5MM

    MDR report key: 1211845 · Received August 12, 2008

    Report

    Report Number
    1211845
    Event Type
    Malfunction
    Date Received
    August 12, 2008
    Date of Event
    March 4, 2008
    Report Date
    August 11, 2008
    Manufacturer
    COVIDIEN VALLEYLAB
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC SURGERY THE SURGEON ATTEMPTED TO USE ENDO CLIP 5MM APPLIER(3 DIFFERENT ENDOCLIPS), BUT THE APPLIER WOULD NOT FIRE CLIPS. ALL THREE HAD THE SAME LOT NUMBER, AND EXPIRATION DATE. THE FOURTH ONE WORKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 (1) ENDO CLIP 5MM CLIP APPLIER GDO COVIDIEN VALLEYLAB * N8A418

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR