BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYRUS UTERINE MANIPULATOR

    MDR report key: 18898370 · Received March 12, 2024

    Report

    Report Number
    MW5152804
    Event Type
    Injury
    Date Received
    March 12, 2024
    Date of Event
    March 5, 2024
    Report Date
    March 11, 2024
    Manufacturer
    OLYMPUS CORPORATION OF THE AMERICAS
    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

    GYRUS UTERINE MANIPULATOR 4.5MM REF 003276, LOT 05032320, EXP 04-01-2026 MANIPULATOR INSERTED FOR PROCEDURE (SUPRACERVICAL HYSTERECTOMY WITH LEFT OVARIAN CYSTECTOMY). DURING PROCEDURE THE TIP OF THE MANIPULATOR BROKE APPROXIMATELY 1 INCH FROM TIP. HAND PORTION OF MANIPULATOR REMOVED VAGINALLY. BROKEN PORTION REMOVED THROUGH SURGICAL INCISION. BOTH PIECED EXAMINED; DETERMINED TO BE COMPLETE. PATIENT EXAMINED BY DR. (B)(6)WITH NO INJURY NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1266781 GYRUS UTERINE MANIPULATOR CANNULA, MANIPULATOR/INJECTOR, UTERINE LKF OLYMPUS CORPORATION OF THE AMERICAS 003276 05032320

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention