BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEARVIEW UTERINE MANIPULATOR

    MDR report key: 6186487 · Received December 19, 2016

    Report

    Report Number
    1722684-2016-00004
    Event Type
    Injury
    Date Received
    December 19, 2016
    Date of Event
    April 18, 2016
    Report Date
    December 17, 2016
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    LKF
    UDI-DI
    00814247020604
    PMA / PMN Number
    K940681
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR IFU 050-0709 REV. B CLEARLY DIFFERENTIATES BETWEEN THE TWO LUMENS AND INDICATES WHAT VOLUME IS REQUIRED TO INFLATE THE BALLOON.

    Description of Event or Problem · 1

    DURING A SURGERY THE TUBES SHOULD BE FLUSHED TO EVALUATE IF ONE OR TWO TUBES SHOULD BE REMOVED. THE CLEAR VIEW IS INSERTED INTO THE UTERUS AND TO KEEP IT THERE 2-3 ML SALTED WATER IS INFUSED TO FILL A SMALL BALLOON. THERE ARE TWO TUBES ONE TO FILL THE BALLOON AND ONE FOR INJECTION OF CONTRAST FLUID. DURING THE OPERATION THE CONTRAST FLUID WAS CONNECTED TO THE WRONG TUBE AND THE BALLOON INSIDE THE UTERUS WAS INFLATED FURTHER AND THE PRESSURE IN THE UTERUS BECAME SO HIGH, THAT THE UTERUS BLEW IN THE TOP OF UTERUS. THE CONSEQUENCE OF THE INCIDENCE IS THAT THE PATIENCE IS NOT RECOMMENDED TO PERFORM A VAGINAL BIRTH AS THE RISK OF RUPTURE OF UTERUS IS HIGH DURING BIRTH. BESIDES THAT IT IS NOT RECOMMENDED TO GET PREGNANT FOR THE NEXT 3 MONTHS WHICH IS A BURDEN AS THE PATIENT ALREADY IS A FERTILITY PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837449 CLEARVIEW UTERINE MANIPULATOR UTERINE MANIPULATOR LKF CLINICAL INNOVATIONS, LLC 151295 00814247020604

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S