BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSA ONE

    MDR report key: 15102244 · Received July 26, 2022

    Report

    Report Number
    3009185973-2022-00036
    Event Type
    Injury
    Date Received
    July 26, 2022
    Date of Event
    July 18, 2022
    Report Date
    September 6, 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
    NY, 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. A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND CONCLUDED THAT THE INACCURACY OF THE ELECTRODES PLACEMENT REGARDING THE PLAN IS CONFIRMED AND IS LIKELY DUE TO THE INCORRECT FUSION OF PRE-OPERATIVE EXAMS. INDEED, THE AUTOMATIC FUSION DID NOT PROVIDE A CORRECT RESULT AND IT WAS NOT RE-ADJUSTED BY USER AS RECOMMENDED IN THE USER MANUAL. THIS ERROR COULD CONTRIBUTE TO THE HEMORRHAGE. ALTHOUGH THE DEVICE BEHAVED AS EXPECTED ¿ THE INCORRECT AUTOMATIC FUSION RESULT CAN BE RELATED TO A PERFORMANCE ISSUE THAT WILL BE ADDRESSED THROUGH THE CONTINUOUS IMPROVEMENT PROCESS OF OUR PRODUCTS. REGISTRATION: THE VERIFICATION RESULTS PROVIDED INCORRECT OUTPUTS DUE TO THAT THE 3D SEGMENTATION WAS NOT REWORKED PROPERLY BY USER. 2D VIEWS SHOW ACCURATE REGISTRATION RESULTS. THE MOUNTING USED TO PLACE MARKERS IS OFF-LABEL. NEVERTHELESS, 11/13 ELECTRODES PLACEMENT REGARDING THE REGISTERED WERE ACCURATELY PLACED. BOTH SHIFTS OBSERVED ARE NOT ON THE HEMORRHAGE SIDE, INFERIOR TO 2.6 MM, SLIGHTLY FORWARD BUT DO NOT HAVE THE SAME ORIENTATION. THOSE ELEMENTS SHOW THAT THE ERROR IS UNLIKELY DUE TO A ROBOTIC ERROR. HOWEVER, THE CAUSE CANNOT BE CONFIRMED.

    Description of Event or Problem · 0

    THE CT SCAN TAKEN AFTER AN SEEG PROCEDURE SHOWED THAT THE PATIENT HAD A HEMORRHAGE. SURGEON PROCEEDED WITH A CRANIOTOMY AND WAS ABLE TO STOP THE BLEEDING. FIELD SERVICE ENGINEER MERGED THE CT TO THE PATIENT¿S PLAN AND NOTED THAT SEVERAL TRAJECTORIES WERE DEVIATED AND CURVED.

    Description of Event or Problem · 0

    THE CT SCAN TAKEN AFTER AN SEEG PROCEDURE SHOWED THAT THE PATIENT HAD A HEMORRHAGE. SURGEON PROCEEDED WITH A CRANIOTOMY AND WAS ABLE TO STOP THE BLEEDING. FIELD SERVICE ENGINEER MERGED THE CT TO THE PATIENT¿S PLAN AND NOTED THAT SEVERAL TRAJECTORIES WERE DEVIATED AND CURVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369498 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