BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEARVIEW UTERINE MANIPULATOR

    MDR report key: 19701447 · Received July 8, 2024

    Report

    Report Number
    MW5157115
    Event Type
    Injury
    Date Received
    July 8, 2024
    Date of Event
    June 19, 2024
    Report Date
    July 3, 2024
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    LKF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT PRESENTED TO CLINIC FOR FOLLOW UP POST HOSPITAL D&C AND HYSTEROSCOPY ON (B)(6) 2024. PATIENT REPORTED TO PROVIDER THAT SHE HAD EXPELLED WHITE PIECES OF FOREIGN BODY FROM HER VAGINA POST PROCEDURE. VENDOR WAS CONTACTED TO DETERMINE IF PIECES WERE RADIOPAQUE BUT WAS UNABLE TO CONFIRM. X-RAYS WITHOUT GEL DID OUTLINE ONE ADDITIONAL FOREIGN BODY IN THE VAGINA. PATIENT WAS RETURNED TO SURGERY TO REMOVE; 2 ADDITIONAL PIECES WERE FOUND DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973713 CLEARVIEW UTERINE MANIPULATOR CANNULA, MANIPULATOR/INJECTOR, UTERINE LKF CLINICAL INNOVATIONS, LLC UM700 231412

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Hospitalization