BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURY UTERINE MANIPULATOR

    MDR report key: 18621453 · Received February 1, 2024

    Report

    Report Number
    18621453
    Event Type
    Malfunction
    Date Received
    February 1, 2024
    Date of Event
    October 12, 2023
    Report Date
    October 16, 2023
    Manufacturer
    GYNEX CORPORATION
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING SURGERY, UTERINE MANIPULATOR BROKE WHILE IN USE. THE TIP OF THE MANIPULATOR BROKE OFF AND WAS RETAINED IN PATIENT'S UTERUS. BROKEN TIP WAS RETRIEVED WITH POLYP FORCEPS REQUIRING NO ADDITIONAL CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414848 CENTURY UTERINE MANIPULATOR CANNULA, MANIPULATOR/INJECTOR, UTERINE LKF GYNEX CORPORATION 10-160 A230619

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown