BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSUTURE PREMIUM SURGICLIP SMALL 9.0

    MDR report key: 1792007 · Received August 4, 2010

    Report

    Report Number
    1792007
    Event Type
    Malfunction
    Date Received
    August 4, 2010
    Date of Event
    July 23, 2010
    Report Date
    August 4, 2010
    Manufacturer
    COVIDIEN
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    AUTOSUTURE PREMIUM SURGICLIP SMALL-9.0 CLIPS FAILED TO OCCLUDE VESSEL, RESULTING IN UNNECCESARY BLOOD LOSS & MORE DISSECTION AROUND THE VESSAL TO GET CONTROL OF THE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSUTURE PREMIUM SURGICLIP SMALL 9.0 APPLIER, SURGICAL, CLIP GDO COVIDIEN * *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR