BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZANNANTI MANIPULATOR

    MDR report key: 6128507 · Received November 28, 2016

    Report

    Report Number
    6128507
    Event Type
    Malfunction
    Date Received
    November 28, 2016
    Date of Event
    October 18, 2016
    Report Date
    October 24, 2016
    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

    PATIENT'S SPOUSE CALLED TO REPORT THAT PATIENT FELT A PLASTIC PIECE IN VAGINA. REPORTED A FOUR INCH SMALL PLASTIC PIECE WAS REMOVED. SURGEON WAS CALLED AND HE CONTACTED THE PATIENT. SPOKE WITH OPERATING ROOM AND SAID IT WAS MOST LIKELY FROM THE HUMI UTERINE MANIPULATOR. SPOKE WITH PATIENT. MET THEM AT SURGEON'S OFFICE, AND THEY PRESENTED THE PIECE WHICH HAD BEEN REMOVED. THE PIECE WAS A SEGMENT OF THE UTERINE MANIPULATOR. PATIENT INSTRUCTED TO OBSERVE FOR ANY OTHER CHANGES, SIGNS, OR SYMPTOMS AND TO CALL WITH ANY QUESTIONS OR CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780364 ZANNANTI MANIPULATOR CANNULA, MANIPULATOR, INJECTOR, UTERINE LKF CATHETER RESEARCH, INC. TMI1151 Q374D

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other NOT IN THE AREA WHERE THE DEVICE WAS BEING USED