BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE BRAIN + SPINE

    MDR report key: 14072895 · Received April 11, 2022

    Report

    Report Number
    3009185973-2022-00028
    Event Type
    Malfunction
    Date Received
    April 11, 2022
    Date of Event
    March 15, 2022
    Report Date
    May 19, 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
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. UDI# :(B)(4).

    Additional Manufacturer Narrative · 0

    DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. THIS ANALYSIS CONCLUDED THAT AN INACCURACY OF 4.4 MM IS CONFIRMED FOR THE ENTRY POINT OF THE TRAJECTORY. THE CAUSE FOR THE INACCURACY IS UNKNOWN. IT COULD HAVE BEEN CAUSED BY A MOVEMENT OF THE HEAD BUT NOTHING PERMITS TO CONFIRM THIS HYPOTHESIS. THE FOLLOWING ELEMENTS WERE NOTICED DURING ANALYSIS AND MAY HAVE IMPACTED THE ACCURACY. HOWEVER, THEY ARE NOT SUFFICIENT TO EXPLAIN THE INACCURACY. - SMALL FUSION ERROR BETWEEN PRE-OPERATIVE CT AND PRE-OPERATIVE MRI . - THE VERIFICATION POINT ON THE FOREHEAD WAS OFF DESPITE RESTARTING SEVERAL TIMES THE REGISTRATION, AND THE MATCHING FRAME SHOWS THAT THE AUTOMATIC SCANNING IS ONLY PARTIALLY VISIBLE ON THE FOREHEAD. THEREFORE, THE INACCURATE REGISTRATION COULD BE A FACTOR OF THE SHIFT OBSERVED. THAT COULD BE DUE TO A DISCREPANCY BETWEEN THE MODEL AND REALITY.

    Description of Event or Problem · 0

    AFTER PERFORMING THE FIRST CONTACTLESS REGISTRATION, THE FIELD SERVICE ENGINEER (FSE) NOTICED THE POINT AT THE TOP OF THE FOREHEAD APPEARED TO BE OFF THE SKIN, BUT ALL OTHER POINTS APPEARED TO BE ON THE SKIN. THERE WERE NO ERROR MESSAGES THAT APPEARED, SO THE FSE MOVED ONTO THE VERIFICATION. DURING VERIFICATION, MOST POINTS APPEARED TO BE WITHIN THE RED CIRCLE FOR ACCURACY, BUT AT THE TOP OF THE FOREHEAD THE POINT WAS CLEARLY OFF THE SKIN AND INACCURATE. IT WAS DECIDED THAT THE REGISTRATION WAS TO BE RE-DONE, BUT THE SAME RESULT OCCURRED AFTER THE SECOND REGISTRATION. A NEW CT WAS LOADED INTO THE SOFTWARE AND WAS USED FOR THE 3D MODEL FOR CONTACTLESS REGISTRATION, BUT THE SAME RESULT APPEARED FOR THE THIRD AND FOURTH REGISTRATION ATTEMPT. SINCE THE ROBOT WAS NOT GIVING AN IN-ACCURACY MESSAGE, THE SURGEON DECIDED TO PROCEED WITH THE SURGERY. AFTER THE ONE TRAJECTORY WAS PLACED, THE POST-OPERATIVE SCAN WAS TAKEN AND MERGED INTO THE SOFTWARE. THE LEAD WAS OFF AT ENTRY BY 5MM OR SO, AND WAS PLACED INACCURATELY. THE FSE MADE SURE THERE WAS NOTHING PULLING ON ANY OF THE PATIENT'S SKIN DURING THE REGISTRATION, AND THE FSE DID NOT NOTICE ANYTHING AFFECTING THE 3D MODEL FROM THE PRE-OPERATIVE CT SCAN. THE ISSUE WAS PERSISTENT FOR ALL 4 REGISTRATION ATTEMPTS, BUT THERE WAS NO OBVIOUS REASONING TO WHY IT WAS OCCURRING. THE PRE-OPERATIVE CT WAS TAKEN THE DAY BEFORE SURGERY ((B)(6) 2022). THERE WAS NO PATIENT IMPACT.

    Description of Event or Problem · 0

    ON THE SKIN. THERE WERE NO ERROR MESSAGES THAT APPEARED, SO THE FSE MOVED ONTO THE VERIFICATION. DURING VERIFICATION, MOST POINTS APPEARED TO BE WITHIN THE RED CIRCLE FOR ACCURACY, BUT AT THE TOP OF THE FOREHEAD THE POINT WAS CLEARLY OFF THE SKIN AND INACCURATE. IT WAS DECIDED THAT THE REGISTRATION WAS TO BE RE-DONE, BUT THE SAME RESULT OCCURRED AFTER THE SECOND REGISTRATION. A NEW CT WAS LOADED INTO THE SOFTWARE AND WAS USED FOR THE 3D MODEL FOR CONTACTLESS REGISTRATION, BUT THE SAME RESULT APPEARED FOR THE THIRD AND FOURTH REGISTRATION ATTEMPT. SINCE THE ROBOT WAS NOT GIVING AN IN-ACCURACY MESSAGE, THE SURGEON DECIDED TO PROCEED WITH THE SURGERY. AFTER THE ONE TRAJECTORY WAS PLACED, THE POST-OPERATIVE SCAN WAS TAKEN AND MERGED INTO THE SOFTWARE. THE LEAD WAS OFF AT ENTRY BY 5MM OR SO, AND WAS PLACED INACCURATELY. THE FSE MADE SURE THERE WAS NOTHING PULLING ON ANY OF THE PATIENT'S SKIN DURING THE REGISTRATION, AND THE FSE DID NOT NOTICE ANYTHING AFFECTING THE 3D MODEL FROM THE PRE-OPERATIVE CT SCAN. THE ISSUE WAS PERSISTENT FOR ALL 4 REGISTRATION ATTEMPTS, BUT THERE WAS NO OBVIOUS REASONING TO WHY IT WAS OCCURRING. THE PRE-OPERATIVE CT WAS TAKEN THE DAY BEFORE SURGERY ((B)(6) 2022). THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1580970 ROSA ONE BRAIN + SPINE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SAS ROSA ONE 3.1 3.1.5.28

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown