BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSA ONE

    MDR report key: 13058933 · Received December 22, 2021

    Report

    Report Number
    3009185973-2021-00187
    Event Type
    Injury
    Date Received
    December 22, 2021
    Date of Event
    November 22, 2021
    Report Date
    January 27, 2022
    Manufacturer
    MEDTECH SAS
    Product Code
    HAW
    PMA / PMN Number
    K200511
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT : THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Additional Manufacturer Narrative · 0

    AN ANALYSIS OF THE DEVICE DATA LOGS AND OF THE PATIENT FILE WAS PERFORMED. THIS ANALYSIS CONCLUDED THAT THE INACCURACY AT THE ENTRY POINT IS CONFIRMED FOR ALL THE FIFTEEN TRAJECTORIES IMPLANTED. ELEVEN ELECTRODES WERE IMPLANTED FURTHER THAN EXPECTED. NO ROBOTIC OR FUNCTIONAL ERROR WAS FOUND AND THE ELEMENTS OF ANALYSIS INDICATE THAT THE DEVICE BEHAVED AS EXPECTED. NOTE THAT THE ELECTRODE DEPTH INSIDE THE BRAIN DEPENDS ON THE METHOD OF IMPLANTATION. THE DEVIATION ANALYSIS SHOWS THAT ALL ELECTRODES ARE DEVIATED IN THE SAME DIRECTION AND COULD BE THE RESULT OF AN UNEXPECTED MOVEMENT OF THE PATIENT'S HEAD AFTER THE REGISTRATION. THE LASER REGISTRATION RESULTS ARE CORRECT BUT NOT OPTIMAL. AS THE ENTRY POINTS WERE NOT CHECKED WITH THE LASER PRIOR TO NAVIGATION WITH THE INSTRUMENT HOLDER, A POTENTIAL MOVEMENT OF THE HEAD COULD HAVE REMAINED UNNOTICED. THE REGISTRATION RESULTS WERE NOT OPTIMAL POSSIBLY DUE TO THE REFERENCE EXAM USED (1.5T MRI). A REVIEW OF THE IFU CONFIRMED THAT RECOMMENDATIONS ARE ADEQUATELY PROVIDED TO UNDERLINE THE IMPORTANCE OF THE 3D EXAM REFERENCE CHOICE AND QUALITY TO ENSURE THE ACCURACY OF THE REGISTRATION. BASED ON THE INVESTIGATION PERFORMED, THE TECHNICAL ROOT CAUSE OF THE EVENT REMAINS UNKNOWN.

    Description of Event or Problem · 0

    A SYMPTOMATIC BLEEDING COMPLICATION WAS REPORTED ON A TRAJECTORY DEVIATION AT THE ENTRY POINT FOR THE FCA' TRAJECTORY.

    Description of Event or Problem · 0

    A SYMPTOMATIC BLEEDING COMPLICATION WAS REPORTED ON A TRAJECTORY DEVIATION AT THE ENTRY POINT FOR THE FCA' TRAJECTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1966480 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SAS ROSA ONE 3.1.5.28

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other