BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIUM SURGICLIP AUTOSUTURE CLIP APPLIER

    MDR report key: 3010253 · Received March 18, 2013

    Report

    Report Number
    3010253
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 18, 2013
    Manufacturer
    COVIDIEN
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    COVIDIEN BRAND SMALL CLIP APPLIER DISCHARGED/DROPPED CLIPS INTO THE WOUND. IT ALSO MALFUNCTIONED IN THE SENSE THAT THE CLIPS DO NOT COME TOGETHER PROPERLY AND THEY "SCISSOR" WHICH CAUSE THEM TO DAMAGE THE VEIN. WE HAVE HAD SIMILAR PROBLEMS WITH THIS PRODUCT BEFORE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112565 PREMIUM SURGICLIP AUTOSUTURE CLIP APPLIER APPLIER, SURGICAL, CLIP FZP COVIDIEN * P2H0418X

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR