BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UTERINE MANIPULATOR/INJECTOR

    MDR report key: 6398604 · Received March 13, 2017

    Report

    Report Number
    6398604
    Event Type
    Malfunction
    Date Received
    March 13, 2017
    Date of Event
    February 24, 2017
    Report Date
    March 6, 2017
    Manufacturer
    CATHETER RESEARCH, INC.
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HUMI UTERINE MANIPULATOR BROKE DURING SURGERY WHILE THE FIRST ASSIST WAS MANIPULATING THE UTERUS. MANIPULATOR WAS REMOVED AND REPLACED BY SURGEON IN ORDER TO PROCEED WITH SURGERY. PART OF THE MANIPULATOR WAS LEFT IN THE VAGINA UNTIL RETRIEVED AT THE END OF THE SURGERY CASE. BOTH PIECES OF THE HUMI MANIPULATOR WERE REMOVED AT THE END OF CASE WITH NO HARM TO THE PATIENT. MANIPULATOR SAVED. HUMI WAS BROKEN AT THE END WHERE THE SYRINGE TUBING IS CONNECTED TO THE PLASTIC.(PLEASE NOTE: NO ALCOHOL WAS USED ON THIS PRODUCT.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182580 UTERINE MANIPULATOR/INJECTOR CANNULA, MANIPULATOR/INJECTOR, UTERINE LKF CATHETER RESEARCH, INC. R671I

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR