BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-CARE UTERINE MANIPULATOR

    MDR report key: 1883576 · Received October 11, 2010

    Report

    Report Number
    1883576
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 11, 2010
    Manufacturer
    CONMED
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    THIS DISPOSABLE CERVIX MANIPULATOR WAS INSERTED INTO THE VAGINA AND CERVIX. UPON REMOVAL THE CUP AT THE END OF THE MANIPULATOR CAME OFF OF THE SHAFT OF THE PRODUCT. THE CUP WAS RETRIEVED AND THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-CARE UTERINE MANIPULATOR UTERINE MANIPULATOR LKF CONMED * 1006252

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR