BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 8054525 · Received November 9, 2018

    Report

    Report Number
    3009185973-2018-00299
    Event Type
    Malfunction
    Date Received
    November 9, 2018
    Date of Event
    October 24, 2018
    Report Date
    January 22, 2019
    Manufacturer
    MEDTECH SA
    Product Code
    HAW
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE 3D MODEL OF THE CT SCAN DISAPPEARED WHEN THE SURGEON TRIED TO CHANGE THE 3D SEGMENTATION LEVEL ON THE PLANNING STATION. A DHR AND A COMPLAINT HISTORY REVIEW WAS PERFORMED AND DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. THE INVESTIGATION CONCLUDED THAT THE CAUSE OF THE ISSUE IS A KNOWN DESIGN DEFECT RECORDED UNDER THE REFERENCE AR-1784. (B)(4). THE DEVICE MODEL ROSA ONE IS NOT FDA CLEARED BUT IS SIMILAR TO THE DEVICE ROSA BRAIN 3.0, CLASSIFIED HAW AND CLEARED UNDER K172444.

    Description of Event or Problem · 0

    ON WEDNESDAY 24 OCTOBER, THE SURGEON TOLD DIRECTLY TO THE FIELD SERVICE ENGINEER (FSE) THAT THE 3D MODEL OF THE CT SCAN DISAPPEARED WHEN HE TRIED TO CHANGE THE 3D SEGMENTATION LEVEL ON THE PLANNING STATION. THIS EVENT OCCURS DURING THE PLANNING OF A BIOPSY, THE PROBLEM WAS SOLVED BY DOING DIRECTLY THE PLANNING ON THE ROBOT. AFTER SOME TEST ON THE PLANNING STATION LAPTOP, THIS ISSUE IS REPEATABLE ON EACH PATIENT FOLDER ( WITH CT AND IRM ) ON THE LAPTOP IN ROSA BRAIN SOFTWARE 3.1.0 BUT IT WORKED ON THE MAINTENANCE SESSION AND ON THE ROBOT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.  THE DEVICE MODEL ROSA ONE IS NOT FDA CLEARED BUT IS SIMILAR TO THE DEVICE ROSA BRAIN 3.0, CLASSIFIED HAW AND CLEARED UNDER K172444. UDI NUMBER: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6), THE SURGEON TOLD DIRECTLY TO THE FIELD SERVICE ENGINEER (FSE) THAT THE 3D MODEL OF THE CT SCAN DISAPPEARED WHEN HE TRIED TO CHANGE THE 3D SEGMENTATION LEVEL ON THE PLANNING STATION. THIS EVENT OCCURS DURING THE PLANNING OF A BIOPSY, THE PROBLEM WAS SOLVED BY DOING DIRECTLY THE PLANNING ON THE ROBOT. AFTER SOME TEST ON THE PLANNING STATION LAPTOP, THIS ISSUE IS REPEATABLE ON EACH PATIENT FOLDER ( WITH CT AND IRM ) ON THE LAPTOP IN ROSA BRAIN SOFTWARE 3.1.0 BUT IT WORKED ON THE MAINTENANCE SESSION AND ON THE ROBOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893852 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA 3.1.0.1276

    Patients

    Seq Age Sex Outcome Treatment
    1