BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARVIEW UTERINE MANIPULATOR

    MDR report key: 10448581 · Received August 24, 2020

    Report

    Report Number
    MW5096241
    Event Type
    Malfunction
    Date Received
    August 24, 2020
    Date of Event
    July 2, 2020
    Report Date
    August 21, 2020
    Manufacturer
    CLINICAL INNOVATIONS, INC.
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RETAINED FOREIGN OBJECT. THE SMALL CAP/SPACER THAT IS A PART OF THE CLEAR VIEW UTERINE MANIPULATOR THAT IS USED IN GYN SURGERIES CAME LOOSE AND WAS FOUND 2 WEEKS LATER, AT THE POST-OP CHECKUP, IN THE PATIENT'S VAGINA. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910907 CLEARVIEW UTERINE MANIPULATOR CANNULA, MANIPULATOR/INJECTOR, UTERINE LKF CLINICAL INNOVATIONS, INC. UM700 192294

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR