BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE BRAIN + SPINE

    MDR report key: 12916645 · Received December 2, 2021

    Report

    Report Number
    3009185973-2021-00183
    Event Type
    Malfunction
    Date Received
    December 2, 2021
    Date of Event
    November 3, 2021
    Report Date
    December 15, 2021
    Manufacturer
    MEDTECH SAS
    Product Code
    HAW
    PMA / PMN Number
    K200511
    Removal / Correction Number
    Z-0118-2022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED. THIS ANALYSIS CONCLUDED THAT DURING GUIDANCE, THE SOFTWARE FROZE DUE TO AN OVERLAPPING OF TWO COMMANDS. THIS IS A KNOWN SOFTWARE ANOMALY. SHUTTING DOWN AND RESTARTING THE DEVICE SOLVED THE ISSUE. LATER IN GUIDANCE, THE SOFTWARE PROMPTED AN UNEXPECTED EMPTY CALIBRATION DUE TO A KNOWN SOFTWARE ANOMALY. THE USER CANCELLED THE EMPTY CALIBRATION AND COULD CONTINUE THE SURGERY. REFER TO FIELD ACTION FDA REFERENCE Z-0118-2022. CORRECTED DATA: - B4 DATE OF THIS REPORT. - G3 DATE RECEIVED BY MANUFACTURER. - H2 IF FOLLOW-UP, WHAT TYPE. - H3 DEVICE EVALUATED BY MANUFACTURER. - H6 ADVERSE EVENT PROBLEM. - H7 REMEDIAL ACTION. - H10 ADDITIONAL NARRATIVES/DATA.

    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. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT : 1. WHEN IN GUIDANCE MODE DRIVING TO TRAJECTORY, ROBOT PROMPTED VIGILANCE DEVICE FAILURE MESSAGE, HOWEVER THE ARM CONTINUED MOVEMENT WITH THE STOP SYMBOL OVERLAYING THE VIGILANCE FAILURE ERROR. COMPANY REPRESENTATIVE (CR) IMMEDIATELY RECOGNIZED THIS AS A SOFTWARE MALFUNCTION AND INSTRUCTED SURGEON TO STEP OFF THE VIGILANCE DEVICE. ROBOTIC ARM MOVEMENT STOPPED HOWEVER THE VIGILANCE DEVICE ICON DISAPPEARED SHOWING JUST AN EMPTY GREY BOX. NEITHER THE BUTTONS NOR THE MOUSE WAS RESPONSIVE, SO CR FIRST ATTEMPTED A SYSTEM RESET. THE SYSTEM POWER BUTTON WAS UNRESPONSIVE AND DID NOT CHANGE FROM BLUE TO RED. CR THEN PERFORMED A FULL MANUAL SHUTDOWN INCLUDING DISCONNECTING POWER FOR 1 MINUTE. AFTER MANUAL SHUT DOWN, SYSTEM REBOOTED NORMALLY. 2. UPON RE-STARTING, ROBOT RECOGNIZED IT WAS NOT IN THE PARKING POSITION. IMMEDIATELY UPON MOVING TOWARDS THE PARKING POSITION ROBOT PROMPTED AN EMPTY CALIBRATION. CR IMMEDIATELY RECOGNIZED THIS AS FIELD ACTION SEQUENCE OF EVENTS (ZFA-2021-00198) AND HIT UNDO. CR DROVE THE ROBOTIC ARM HOME, RE-SELECTED THE SAVED CALIBRATION FOR THE INSTRUMENT HOLDER, AND RE-DROVE TO THE TRAJECTORY. THESE EVENTS OCCURRED DURING SURGERY AND CAUSED A PROCEDURE DELAY OF 15 MINUTES, BUT HAD NO PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: 1. WHEN IN GUIDANCE MODE DRIVING TO TRAJECTORY, ROBOT PROMPTED VIGILANCE DEVICE FAILURE MESSAGE, HOWEVER THE ARM CONTINUED MOVEMENT WITH THE STOP SYMBOL OVERLAYING THE VIGILANCE FAILURE ERROR. COMPANY REPRESENTATIVE (CR) IMMEDIATELY RECOGNIZED THIS AS A SOFTWARE MALFUNCTION AND INSTRUCTED SURGEON TO STEP OFF THE VIGILANCE DEVICE. ROBOTIC ARM MOVEMENT STOPPED HOWEVER THE VIGILANCE DEVICE ICON DISAPPEARED SHOWING JUST AN EMPTY GREY BOX. NEITHER THE BUTTONS NOR THE MOUSE WAS RESPONSIVE, SO CR FIRST ATTEMPTED A SYSTEM RESET. THE SYSTEM POWER BUTTON WAS UNRESPONSIVE AND DID NOT CHANGE FROM BLUE TO RED. CR THEN PERFORMED A FULL MANUAL SHUTDOWN INCLUDING DISCONNECTING POWER FOR 1 MINUTE. AFTER MANUAL SHUT DOWN, SYSTEM REBOOTED NORMALLY. 2. UPON RE-STARTING, ROBOT RECOGNIZED IT WAS NOT IN THE PARKING POSITION. IMMEDIATELY UPON MOVING TOWARDS THE PARKING POSITION ROBOT PROMPTED AN EMPTY CALIBRATION. CR IMMEDIATELY RECOGNIZED THIS AS FIELD ACTION SEQUENCE OF EVENTS (ZFA-2021-00198) AND HIT UNDO. CR DROVE THE ROBOTIC ARM HOME, RE-SELECTED THE SAVED CALIBRATION FOR THE INSTRUMENT HOLDER, AND RE-DROVE TO THE TRAJECTORY. THESE EVENTS OCCURRED DURING SURGERY AND CAUSED A PROCEDURE DELAY OF 15 MINUTES, BUT HAD NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1814708 ROSA ONE BRAIN + SPINE ROSA ONE HAW MEDTECH SAS ROSA ONE 3.1.5.28

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown