BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCARE

    MDR report key: 3231184 · Received July 2, 2013

    Report

    Report Number
    3231184
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 20, 2013
    Report Date
    July 2, 2013
    Manufacturer
    CONMED CORPORATION
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LARGE V-CARE UTERINE MANIPULATOR CAME APART WHILE REMOVING THE UTERUS FROM THE VAGINA. NO HARM TO PATIENT OR STAFF.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?HYSTERECTOMY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300779 VCARE CANNULA, MANIPULATOR/INJECTOR, UTERINE LKF CONMED CORPORATION * 1211201

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR