BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 15102392 · Received July 26, 2022

    Report

    Report Number
    3009185973-2022-00037
    Event Type
    Malfunction
    Date Received
    July 26, 2022
    Date of Event
    July 11, 2022
    Report Date
    November 10, 2022
    Manufacturer
    MEDTECH SAS
    Product Code
    HAW
    UDI-DI
    03760244032492
    PMA / PMN Number
    K214065
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    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

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED, UPDATED: D4; H2; H3; H6. A PREVENTIVE MAINTENANCE FOR THE DEVICE WAS PERFORMED WHERE THE RSI BOARD, SOFTWARE, AND FOOT PEDAL WERE UPGRADED. THE DEVICE WAS RELEASED CONFORMING AND FUNCTIONING AS INTENDED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. BASED ON THE INVESTIGATION PERFORMED, THE TECHNICAL ROOT CAUSE OF THE EVENT WAS DETERMINED TO BE NO FAILURE DETECTED, DEVICE OPERATED WITHIN SPECIFICATION. THE REPORTED EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE WHILE IN ZIMMER BIOMET CONTROL. THE DEVICE WAS RELEASED CONFORMING AND FUNCTIONING AS INTENDED. COMPLAINT IS UNCONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    AFTER THE SOFTWARE UPGRADE OF THE ROBOT, THE ARM MOVED IN FROM THE OPPOSITE DIRECTION DURING THE APPLICATIVE TEST. INSTEAD OF MOVING FROM THE TOP TO THE LEFT IT CAME IN FROM THE BOTTOM RIGHT. ON THE FOUR TRAJECTORY THE ARM LOCKED ITSELF OUT AND THE EMERGENCY STOP CAME ON. THE ROBOT WAS TURNED OFF AND THE EMERGENCY BUTTON WAS UNPLUGGED AND RE PLUGGED IN. THE ROBOT STARTED WORKING AS NORMAL AFTER.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708219 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SAS ROSA ONE 3.1 3.1.6.90 03760244032492

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown