BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 14072288 · Received April 11, 2022

    Report

    Report Number
    3009185973-2022-00027
    Event Type
    Malfunction
    Date Received
    April 11, 2022
    Date of Event
    March 14, 2022
    Report Date
    April 20, 2022
    Manufacturer
    MEDTECH SAS
    Product Code
    HAW
    PMA / PMN Number
    K200511
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Additional Manufacturer Narrative · 0

    A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND CONCLUDED THE BLANK POPUP AND FREEZE WERE DUE TO THE OVERLAPPING OF TWO COMMANDS, A COOPERATIVE SLOW MODE AND AN AUTOMATIC MOVEMENT. THIS ISSUE WILL BE ADDRESSED THROUGH THE CONTINUOUS IMPROVEMENT PROCESS OF OUR PRODUCTS. ANALYSIS SHOWED THAT THE EVENT IS CONFIRMED. HOWEVER, THE UNEXPECTED ARM MOUVEMENT TO RETURN TO "HOME" POSITION WAS IN FACT A NORMAL BEHAVIOR OF THE DEVICE. INDEED, THE ARM WAS CLEARED AWAY FROM PATIENT, BUT THE SOFTWARE REQUIRES TO PASS BY THE PREDEFINED "INTERMEDIARY POSITION" BEFORE TO MOVE TO "HOME" POSITION. IN THIS CASE THE INTERMEDIARY POSITION WAS CLOSER TO THE PATIENT'S HEAD THAN THE LAST POSITION OF CLERANCE PERFORMED BY THE USER WITHOUT ANY RISK TO TOUCH THE PATIENT OR THE HEAD HOLDER.

    Description of Event or Problem · 0

    THIS EVENT OCCURRED DURING ACCURACY VERIFICATION AFTER FRAME REGISTRATION. AFTER SUCCESSFULLY REGISTERING THE PATIENT WITH THE LEKSELL FRAME AND CALIBRATION PLATES, AN RMS VALUE WAS GIVEN, AND THE SURGEON PROCEEDED TO THE VERIFICATION PROCEDURE BY VALIDATING THE LOCATION OF THE 4 LEKSELL PINS. AFTER COMPLETING VERIFICATION, THE ARM WAS MOVED AWAY FROM THE PATIENT IN COOPERATIVE MODE. THE CLINICAL REPRESENTATIVE (CR) THEN PRESSED THE 'HOME' BUTTON TO TAKE THE ARM BACK TO HOME POSITION. THE ARM BEGAN MOVING CLOSE TO THE CALIBRATION PLATES, SO THE CR PRESSED THE 'STOP' BUTTON TO PAUSE MOVEMENT. THE CR THEN CLICKED 'CLEARING ARM' AND PUT MOVEMENT IN 'FAST AND FREE'. THE SURGEON MOVED THE ARM MANUALLY AWAY FROM THE CALIBRATION PLATES. THE CR THEN CONTINUED CLEARING BACK TO HOME. THE WHITE BOX THAT INDICATES MOVEMENT BECAME BLANK/WHITE AND THE SCREEN WAS FROZEN. THE CR WAITED SEVERAL MINUTES, BUT THE SCREEN REMAINED FROZEN WITH THE ARM STUCK ABOUT HALFWAY TO INTERMEDIATE POSITION. THE ROBOT WAS TURNED OFF AND REBOOTED. FRAME REGISTRATION WAS PERFORMED AGAIN AND WAS COMPLETED SUCCESSFULLY. NO OTHER ISSUES OCCURRED DURING THE PROCEDURE. THIS RESULTED IN AN APPROXIMATE 10 MINUTE DELAY.

    Description of Event or Problem · 0

    THIS EVENT OCCURRED DURING ACCURACY VERIFICATION AFTER FRAME REGISTRATION. AFTER SUCCESSFULLY REGISTERING THE PATIENT WITH THE LEKSELL FRAME AND CALIBRATION PLATES, AN RMS VALUE WAS GIVEN, AND THE SURGEON PROCEEDED TO THE VERIFICATION PROCEDURE BY VALIDATING THE LOCATION OF THE 4 LEKSELL PINS. AFTER COMPLETING VERIFICATION, THE ARM WAS MOVED AWAY FROM THE PATIENT IN COOPERATIVE MODE. THE CLINICAL REPRESENTATIVE (CR) THEN PRESSED THE 'HOME' BUTTON TO TAKE THE ARM BACK TO HOME POSITION. THE ARM BEGAN MOVING CLOSE TO THE CALIBRATION PLATES, SO THE CR PRESSED THE 'STOP' BUTTON TO PAUSE MOVEMENT. THE CR THEN CLICKED 'CLEARING ARM' AND PUT MOVEMENT IN 'FAST AND FREE'. THE SURGEON MOVED THE ARM MANUALLY AWAY FROM THE CALIBRATION PLATES. THE CR THEN CONTINUED CLEARING BACK TO HOME. THE WHITE BOX THAT INDICATES MOVEMENT BECAME BLANK/WHITE AND THE SCREEN WAS FROZEN. THE CR WAITED SEVERAL MINUTES, BUT THE SCREEN REMAINED FROZEN WITH THE ARM STUCK ABOUT HALFWAY TO INTERMEDIATE POSITION. THE ROBOT WAS TURNED OFF AND REBOOTED. FRAME REGISTRATION WAS PERFORMED AGAIN AND WAS COMPLETED SUCCESSFULLY. NO OTHER ISSUES OCCURRED DURING THE PROCEDURE. THIS RESULTED IN AN APPROXIMATE 10 MINUTE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1519883 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