BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 7850281 · Received September 6, 2018

    Report

    Report Number
    3009185973-2018-00241
    Event Type
    Malfunction
    Date Received
    September 6, 2018
    Date of Event
    September 5, 2018
    Report Date
    December 3, 2018
    Manufacturer
    MEDTECH SA
    Product Code
    HAW
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). IT WAS REPORTED THAT IT WAS IMPOSSIBLE TO LOAD PATIENT FOLDER DURING A SURGERY AND THAT FOR A TRAJECTORY THE DEVICE WAS ONLY ABLE TO REACH THE ENTRY POINT WITH A LENGTH OF 138 MM INSTEAD OF THE STANDARD 200 MM. DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. ACCORDING TO TECHNICAL INVESTIGATION, THE EVENT WITH THE PATIENT FOLDER COULD NOT BE REPRODUCED BUT IS CONFIRMED AS A FIELD SERVICE ENGINEER WAS PRESENT DURING THE SURGERY. ALSO, IT IS NORMAL BEHAVIOR FROM THE DEVICE TO ADJUST THE LENGTH OF THE TRAJECTORY DEPENDING ON THE POINT THAT NEED TO BE REACHED. NO FAILURE OF THE DEVICE CAN BE CONFIRMED FOR THIS EVENT.

    Description of Event or Problem · 0

    A MEDTECH FIELD SERVICE ENGINEER (FSE) ASSISTED THE SURGEON TO TRY TO IMPORT THE PATIENT FOLDER FROM A USB. THE SOFTWARE DISPLAYED AN ERROR MESSAGE. THE IMPORT NOT SUCCESSFUL. THE FSE TRIED AGAIN TO IMPORT AND THE ROSANNA SOFTWARE ASKED TO OVERWRITE THE PATIENT FOLDER. THE FSE SELECTED YES AND THE IMPORT WAS AGAIN NOT SUCCESSFUL. TO RESOLVE THE ISSUE, THE FSE LOADED THE IMPORTED PATIENT FOLDER FROM THE ROBOT DIRECTLY AND THIS WAS SUCCESSFUL. THE SURGEON CHECKED AGAIN THE TRAJECTORY AND EVERYTHING WAS SATISFACTORY.

    Additional Manufacturer Narrative · 1

    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. THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION WILL BE PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A MEDTECH FIELD SERVICE ENGINEER (FSE) ASSISTED THE SURGEON TO TRY TO IMPORT THE PATIENT FOLDER FROM A USB. THE SOFTWARE DISPLAYED AN ERROR MESSAGE. THE IMPORT NOT SUCCESSFUL. THE FSE TRIED AGAIN TO IMPORT AND THE ROSANNA SOFTWARE ASKED TO OVERWRITE THE PATIENT FOLDER. THE FSE SELECTED YES AND THE IMPORT WAS AGAIN NOT SUCCESSFUL. TO RESOLVE THE ISSUE, THE FSE LOADED THE IMPORTED PATIENT FOLDER FROM THE ROBOT DIRECTLY AND THIS WAS SUCCESSFUL. THE SURGEON CHECKED AGAIN THE TRAJECTORY AND EVERYTHING WAS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694923 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA ROSA ONE 3.1 3.1.0.1276

    Patients

    Seq Age Sex Outcome Treatment
    1