BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCARE

    MDR report key: 3072397 · Received April 12, 2013

    Report

    Report Number
    3072397
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 12, 2013
    Manufacturer
    CONMED CORPORATION
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BALLOON FOR THIS PRODUCT WOULD NOT WORK.THREE MORE OR THE SAME PRODUCT WERE OPENED AND ALL THREE FAILED.ALL PRODUCTS FROM THIS LOT HAVE BEEN PULLED FROM THE SHELVES AND MANUFACTURER TO BE NOTIFIED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ROBOTIC ASSISTED TOTAL LAP HYSTERECTOMY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158630 VCARE UTERINE MANIPULATOR LKF CONMED CORPORATION * 130108-1

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR