BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOTEQUE TAIWAN LTD.

    MDR report key: 23062841 · Received September 16, 2025

    Report

    Report Number
    23062841
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Date of Event
    July 29, 2025
    Report Date
    August 6, 2025
    Manufacturer
    BIOTEQUE TAIWAN LTD.
    Product Code
    LKF
    UDI-DI
    04719894432878
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT S/P [STATUS POST] LAP OVARIAN CYSTECTOMY AND OOPHORECTOMY. DISTAL PORTION OF ZUMI MANIPULATOR BROKE OFF INSIDE VAGINA. PATIENT DENIES COMPLICATIONS RELATED TO SAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286577 BIOTEQUE TAIWAN LTD. CANNULA, MANIPULATOR/INJECTOR, UTERINE LKF BIOTEQUE TAIWAN LTD. UMI4.5 A240607 04719894432878

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other