BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UTERINE MANIPULATOR INJECTOR - THE MANIPULATOR 4.5

    MDR report key: 24743652 · Received March 31, 2026

    Report

    Report Number
    MW5186181
    Event Type
    Malfunction
    Date Received
    March 31, 2026
    Date of Event
    March 16, 2026
    Report Date
    March 26, 2026
    Manufacturer
    BIOTEQUE AMERICA, INC
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    UTERINE MANIPULATOR BROKE DURING SURGICAL PROCEDURE. MD REPORTS THIS HAS BEEN HAPPENING FREQUENTLY WITH THIS MANIPULATOR. THE DEVICE WAS COMPLETELY REMOVED AND NO DAMAGE TO THE PATIENT WAS NOTICED BY THE SURGICAL TEAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808523 UTERINE MANIPULATOR INJECTOR - THE MANIPULATOR 4.5 CANNULA, MANIPULATOR/INJECTOR, UTERINE LKF BIOTEQUE AMERICA, INC A240607

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Other