BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIO

    MDR report key: 6701382 · Received July 11, 2017

    Report

    Report Number
    6701382
    Event Type
    Malfunction
    Date Received
    July 11, 2017
    Date of Event
    March 14, 2017
    Report Date
    May 2, 2017
    Manufacturer
    BLUE BELT TECHNOLOGIES, INC.
    Product Code
    OLO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE STAFF WAS TRYING TO PASS A DRILL DOWN THE NAVIO'S FINAL ATTACHMENT BEFORE THE CASE STARTED. HE COULD NOT GET THE DRILL TO PASS. LOOKING INSIDE THE PART, IT LOOKS LIKE A METAL RING CAME LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481090 NAVIO ROBOTICS-ASSISTANCE OLO BLUE BELT TECHNOLOGIES, INC. LONG SNJ38311000701

    Patients

    Seq Age Sex Outcome Treatment
    1