BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSA ONE

    MDR report key: 14336203 · Received May 9, 2022

    Report

    Report Number
    3009185973-2022-00030
    Event Type
    Injury
    Date Received
    May 9, 2022
    Date of Event
    April 11, 2022
    Report Date
    September 2, 2022
    Manufacturer
    MEDTECH SAS
    Product Code
    HAW
    PMA / PMN Number
    K200511
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND PERMITTED TO IDENTIFIED THAT THE PATTERN OF AUTOMATIC SCAN ON PATIENT¿S FOREHEAD ¿ WHICH AREA IS USED FOR THE IDENTIFICATION SAMPLE - WAS TOO SMALL IN RELATION TO THE AVAILABLE AREA. THEREFORE, THE REGISTRATION RESULT WAS CORRECT BUT NOT OPTIMAL. IT WAS CONFIRMED THAT THREE ELECTRODES AMONG SEVEN WERE IMPLANTED OVER THE SPECIFICATION LIMIT OF 2 MM AT THE ENTRY POINT. THE DEVIATION OF ELECTRODES SHOWS THAT A ROTATION OF THE HEAD COULD BE THE CAUSE BUT THIS ASSUMPTION CANNOT BE CONFIRMED. THE ELECTRODE RESPONSIBLE FOR THE SUBDURAL HEMATOMA AND THE PATIENT NEUROPATHY ¿ ACCORDING TO THE MEDICAL TEAM - WAS IMPLANTED ACCURATELY IN RELATION TO THE REGISTERED EXAM. ON THIS PARTICULAR TRAJECTORY, THE ROBOT OPERATED AS EXPECTED. ACCORDING TO HEALTH CARE PROFESSIONAL REVIEW, THE HEMORRHAGE IS UNLIKELY DUE TO THE ROBOT USE AND COULD COME FROM ANOTHER ELECTRODE WHICH WAS IMPLANTED SHIFTED. THE CAUSE FOR THE SHIFT COULD BE EXPLAIN BY OTHER FACTORS WHICH CANNOT BE CONFIRMED BY ANALYSIS. THE DHR REVIEW SHOWED THAT DEVICE PASSED THE LAST MAINTENANCE. NO ROBOTIC ERROR WAS FOUND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BRAIN SURGERY WAS PERFORMED WITH ROSA ONE BRAIN ON (B)(6) 2022. IN SEEG ELECTRODE PLACEMENT, SUBDURAL HEMATOMA WAS FOUND BY POSTOPERATIVE CT. POSTOPERATIVE ANESTHESIA AFTER AWAKENING, PARALYSIS WAS CONFIRMED IN THE GRIP STRENGTH AND BEHAVIOR OF THE LEFT FINGERTIP. ABOUT FOUR HOURS AFTER THE SURGERY, THE CONDITION WAS IMPROVED BUT IT WAS RECOGNIZED AS NEUROPATHY. THE CAUSAL RELATIONSHIP WITH THE SITE OF SUBDURAL HEMATOMA IS UNKNOWN. IF PARALYSIS REMAINS, THE ELECTRODE MAY BE REMOVED. THERE WAS NO PROBLEM WITH THE OPERATION OF ROSA DURING THE OPERATION, AND THE CAUSAL RELATIONSHIP WITH THIS COMPLICATION IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BRAIN SURGERY WAS PERFORMED WITH ROSA ONE BRAIN ON (B)(6) 2022. IN SEEG ELECTRODE PLACEMENT, SUBDURAL HEMATOMA WAS FOUND BY POSTOPERATIVE CT. POSTOPERATIVE ANESTHESIA AFTER AWAKENING, PARALYSIS WAS CONFIRMED IN THE GRIP STRENGTH AND BEHAVIOR OF THE LEFT FINGERTIP. ABOUT FOUR HOURS AFTER THE SURGERY, THE CONDITION WAS IMPROVED BUT IT WAS RECOGNIZED AS NEUROPATHY. THE CAUSAL RELATIONSHIP WITH THE SITE OF SUBDURAL HEMATOMA IS UNKNOWN. IF PARALYSIS REMAINS, THE ELECTRODE MAY BE REMOVED. THERE WAS NO PROBLEM WITH THE OPERATION OF ROSA DURING THE OPERATION, AND THE CAUSAL RELATIONSHIP WITH THIS COMPLICATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1534942 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 Other