BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 13058666 · Received December 22, 2021

    Report

    Report Number
    3009185973-2021-00185
    Event Type
    Malfunction
    Date Received
    December 22, 2021
    Date of Event
    November 5, 2021
    Report Date
    April 8, 2022
    Manufacturer
    MEDTECH SAS
    Product Code
    HAW
    PMA / PMN Number
    K200511
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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

    A FULL ANALYSIS OF THE DATA LOGS AND PATIENT FOLDER HAS BEEN PERFORMED AND THIS ANALYSIS CONCLUDED THAT THE INACCURACY IS CONFIRMED FOR SEVEN OUT OF FOURTEEN TRAJECTORIES. HOWEVER, THERE IS ONLY AN INACCURACY BETWEEN THE POST-OPERATIVE CT AND THE PLANNING CT. THERE IS NO INACCURACY BETWEEN THE POST-OPERATIVE CT AND THE REGISTRATION CT. THE FINAL INACCURACY OBSERVED WAS DUE TO AN ERROR OF FUSION BETWEEN THE PRE-OPERATIVE CT AND THE PLANNING CT. THIS IS DUE TO TWO FACTORS: THE FAILURE OF THE AUTOMATIC FUSION, THE USER SHOULD HAVE PERFORMED MANUAL ADJUSTMENTS AND VERIFIED THE FUSION ACCURACY ACCORDING TO RECOMMENDATIONS OF THE USER MANUAL.

    Description of Event or Problem · 0

    THE CLINICAL REPRESENTATIVE (CR) RECEIVED TEXT MESSAGES FROM SURGEON USER DR. (B)(6), WHERE DR. (B)(6) NOTED THAT THE LAST TWO SEEG CASES HAVE BEEN 'OFF AT ENTRANCE AND TARGET'. THE CR NOTED THAT A SUCCESSFUL PREVENTIVE MAINTENANCE PASSED IN THE PAST WEEK.

    Description of Event or Problem · 0

    THE CLINICAL REPRESENTATIVE (CR) RECEIVED TEXT MESSAGES FROM SURGEON USER DR. CURRY WHERE DR. CURRY NOTED THAT THE LAST TWO SEEG CASES HAVE BEEN 'OFF AT ENTRANCE AND TARGET'. THE CR NOTED THAT A SUCCESSFUL PREVENTIVE MAINTENANCE PASSED IN THE PAST WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1966477 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SAS ROSA ONE 3.1 3.1.5.28

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown