BEUDAMED
    FDA Adverse Event Summary report: N

    VESOCCLUDE TITANIUM CLIP

    MDR report key: 5366419 · Received January 8, 2016

    Report

    Report Number
    3007208013-2016-00001
    Date Received
    January 8, 2016
    Date of Event
    December 4, 2015
    Report Date
    January 7, 2016
    Manufacturer
    VESOCCLUDE MEDICAL LLC
    Product Code
    FZP
    PMA / PMN Number
    K091060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    0

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE PROBLEM ALREADY KNOWN, NO EVALUATION NECESSARY. UPON LOADING THE TITANIUM CLIPS INTO THE CLIP APPLIERS, USER WAS LOADING CLIPS AT AN ANGLE AND NOT LOADING THE CLIPS STRAIGHT ON, THUS CAUSING SCRAPING AGAINST THE PLASTIC TRAY CAUSING SHAVING S AND POSSIBLE CLIP MISS-LOAD.

    Description of Event or Problem · 1

    MANAGER FOR OPERATING ROOMS, REPORTED THAT A LIVER TRANSPLANT TEAM HAS BEING EXPERIENCING THE SMALL LIGATION CLIPS ARE RELEASING PIECES OF WHITE COLOR PLASTIC AFTER EACH CARTRIDGE USE. THE SURGEONS WITH THEIR MAGNIFYING GLASSES (LOUPES) ON, THEY ARE SEEING WHITE "STUFF"COME OFF ON THE TISSUE AS THEY ARE DEPLOYING THE CLIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13487 VESOCCLUDE TITANIUM CLIP FZP VESOCCLUDE MEDICAL LLC 20130 3810

    Patients

    Seq Age Sex Outcome Treatment
    1