BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UTERINE MANIPULATOR

    MDR report key: 6900217 · Received September 28, 2017

    Report

    Report Number
    6900217
    Event Type
    Malfunction
    Date Received
    September 28, 2017
    Date of Event
    August 21, 2017
    Report Date
    September 25, 2017
    Manufacturer
    CATHETER RESEARCH, INC. (THOMAS MEDICAL)
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPY PROCEDURE, THE PLASTIC TIP (APPROXIMATELY 1 INCH) OF A DISPOSABLE UTERINE MANIPULATOR BROKE OFF IN A PATIENT'S CERVIX WHILE IN USE BY THE PROCEDURALIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680475 UTERINE MANIPULATOR CANNULA, MANIPULATOR/INJECTOR, UTERINE LKF CATHETER RESEARCH, INC. (THOMAS MEDICAL) UTERINE MANIPULATOR S414C

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR NO OTHER THERAPIES| NO, ONLY A TENACULUM ON THE ANTERIOR LIP OF CERVIX