BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONCENTRA GYN

    MDR report key: 1881191 · Received October 5, 2010

    Report

    Report Number
    9611894-2010-00007
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Manufacturer
    NUCLETRON BV
    Product Code
    MUJ
    PMA / PMN Number
    K080929
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USERS CAN SEE SHIFTS OF APPLICATOR PLACEMENT OF UP TO 3MM AFTER FUSION OF CT AND MR IMAGES. THIS SHIFT IS ALWAYS IN THE SAME DIRECTION AND SEEMS TO BE INDEPENDENT OF THE SLICE SPACING OF THE SCANS. THEY CANNOT BE SURE THAT THE APPLICATOR IS POSITIONED CORRECTLY ON THE IMAGE. THEY ARE ALSO UNSURE AS TO WHETHER THERE IS THE SAME SHIFT IN CONTOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONCENTRA GYN PROSTATE / GYN MUJ NUCLETRON BV

    Patients

    Seq Age Sex Outcome Treatment
    1