BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSA ONE (JP)

    MDR report key: 20022384 · Received August 21, 2024

    Report

    Report Number
    3009185973-2024-00009
    Event Type
    Injury
    Date Received
    August 21, 2024
    Date of Event
    July 22, 2024
    Report Date
    October 30, 2024
    Manufacturer
    MEDTECH SAS
    Product Code
    HAW
    UDI-DI
    03760244034328
    PMA / PMN Number
    K200511
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. INVESTIGATION OF THE LOG FILES WAS PERFORMED BY THE ZIMMER BIOMET PRODUCT SURVEILLANCE TEAM SUBJECT MATTER EXPERT (SME). RESULTS OF THE LOG FILE INVESTIGATION DID NOT CONFIRM ELECTRODE ENTRY DISCREPANCIES NOR INACCURATE REGISTRATION. THE LOGS DID SHOW THE HEMATOMA AND TARGET POINT DISCREPANCIES. THE FOLLOWING FACTS WERE IDENTIFIED IN THE LOGS: ¿ FUSION: THERE WAS SLIGHT FUZZINESS OR DISTORTION FOUND IN THE MRI THAT COULD HAVE CONTRIBUTED TO THE INACCURACIES SEEN. THE FUSION BETWEEN PRE-OPERATIVE POST-OPERATIVE CT EXAMS SHOWS A SMALL SHIFT IN THE SAGITTAL PLANE. ¿ REGISTRATION: AUTOMATIC LASER REGISTRATION WAS PERFORMED AND RESULTING IN PASSING RMS VALUES. THE RMS ERROR WAS 0.603MM, WHICH IS UNDER THE 0.85 MM THRESHOLD. ¿ VERIFICATION: THE DISTANCE ERRORS FOR ALL VERIFICATION POINTS WERE WITHIN THE SYSTEM¿S 2 MM THRESHOLD. THE REGISTRATION VERIFICATION SCREENSHOTS WERE REVIEWED, AND ALL POINTS WERE TAKEN IN THE RECOMMENDED ANATOMICAL LOCATIONS AS INDICATED BY THE SYSTEM. THERE WAS A SMALL SPACE BETWEEN THE SKIN AND THE RED DOT FOR THE LEFT TEMPLE, SEE IMAGE BELOW. THE RED CIRCLE SHOULD TOUCH THE SKIN (WHITE PART) IN AT LEAST ONE OF THE VIEWS. A REVIEW OF THE AUTOMATIC SCANNING SHOWS THE 3D MESH WAS VISIBLE, AND THE POINTS APPEAR TO BE DISTRIBUTED EVENLY ON DIFFERENT PLANS. THEREFORE, THE REGISTRATION VERIFICATION RESULT WAS CORRECT BUT NOT OPTIMAL. ¿ ELECTRODE DEVIATION - ENTRY POINT: THE AVERAGE DEVIATION FOR ENTRY POINTS FOR ALL ELECTRODES WERE UNDER THE SYSTEM¿S 2MM SPECIFICATION LIMIT. BASED OFF THIS INFORMATION, NO INACCURACY WAS FOUND AT ANY ENTRY POINT. ¿ ELECTRODE DEVIATION - TARGET POINT: THERE WERE INACCURACIES WITH THE TARGET POINTS, DEVIATION >2MM. THE ELECTRODES APPEAR TO BE PLACED MORE ANTERIOR THAN PLANNED FOR ALL TARGET POINTS. SPECIFICALLY FOR ELECTRODE ¿INSULA¿, THE FLEXION OF THE INTRACRANIAL ELECTRODE DUE TO THE HEMATOMA, THERE WAS A LARGE DISCREPANCY BETWEEN PLANNED TARGET AND ACTUAL ELECTRODE TIP POSITION. THIS BLEEDING COULD ALSO LEAD TO A DEVIATION ON THE OTHER TARGET POINTS. PER ADDITIONAL INFORMATION, THE USER STATED THE HEMORRHAGE HAPPENED AFTER COMPLETION OF SEEG PROCEDURES AND THEY WERE AWARE THAT THE ELECTRODE TIP CURVED IN THE POSTOPERATIVE BLOOD SEED AREA. THERE WERE NO SOFTWARE ANOMALIES IDENTIFIED WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. ACCORDING THE SURFACE MATCHING REGISTRATION OF THE ROSA ONE BRAIN USER MANUAL, THE RECOMMENDED POSITIONS FOR THE INITIAL POINTS SHOULD BE SCANNED MANUALLY USING THE LASER BEAM ORIENTED PERPENDICULARLY TO THE SKIN SURFACE. THE POINTS SHOULD BE MARKED AT THE SURFACE OF THE SKIN ON INVARIANT AREAS OR THE FIDUCIALS. THERE WERE NO CONFIRMED ELECTRODE ENTRY POINT NOR REGISTRATION INACCURACIES. THE AVERAGE DEVIATION FOR ENTRY POINTS FOR ALL ELECTRODES WERE UNDER THE SYSTEM¿S 2MM SPECIFICATION LIMIT. THE REGISTRATION WAS PERFORMED CORRECTLY, BUT THE VERIFICATION RESULT WAS NOT OPTIMAL. THERE IS NO EVIDENCE TO INDICATE THAT THE ROSA MALFUNCTIONED OR CONTRIBUTED TO THE ADVERSE EVENT. PER ADDITIONAL INFORMATION, THE USER ACKNOWLEDGES THE TARGET POINTS SHIFTED DUE TO THE ELECTRODES BEING PUSHED BY THE POST-OPERATIVE BLEEDING AFTER ALL ELECTRODES WERE PLACED. THE CAUSE OF THE BLEEDING CANNOT BE DETERMINED WITH THE INFORMATION AVAILABLE. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED AND THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A TOTAL OF 7 DEEP INTRACRANIAL ELECTRODES WERE IMPLANTED WITH ROSA ONE. THE PROCEDURE WAS COMPLETED WITHOUT ANY INTRAOPERATIVE FLUOROSCOPIC IMAGING OR PATIENT VITAL SIGN ABNORMALITIES. AFTER SURGERY, THE PATIENT WAS POORLY AWAKE FROM GENERAL ANESTHESIA AND SHOWED SIGNS OF RIGHT-SIDED PARALYSIS. POSTOPERATIVE CT IMAGES CONFIRMED BLEEDING FROM THE MIDDLE CEREBRAL ARTERY (THE ARTERY RUNNING THROUGH THE SYLVIAN FISSURE). THE PATIENT WAS DEEMED TO REQUIRE EMERGENCY TREATMENT AND UNDERWENT A HEMOPERITONEUMECTOMY. THE SURGERY CONTINUED UNTIL LATE IN THE MORNING, BUT THE REMOVAL PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. THE PATIENT IS CURRENTLY IN THE INTENSIVE CARE UNIT UNDER GENERAL ANESTHESIA, AND THE SITUATION IS STILL UNPREDICTABLE. THE SURGEON WILL CONTINUE TO FOLLOW UP ON THE PATIENT'S CONDITION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2359095 ROSA ONE (JP) MULTI-PURPOSE STEREOTACTIC SURGERY SYSTEM HAW MEDTECH SAS N/A 3.1.6.432 03760244034328

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other| H