BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 14367332 · Received May 12, 2022

    Report

    Report Number
    3009185973-2022-00029
    Event Type
    Malfunction
    Date Received
    May 12, 2022
    Date of Event
    April 27, 2022
    Report Date
    June 30, 2022
    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
    FL, 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. UNIQUE IDENTIFIER (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 FIRST DEVICE RESTART WAS DUE TO A COLLISION OF THE ARM WHICH PROVOKED THE DETECTION OF AN OVER FORCE. THE COLLISION COULD HAVE BEEN AVOIDED BY RELEASING THE VIGILANCE DEVICE. AFTER RESTART, THE ARM EMPTY CALIBRATION WAS REQUESTED WHEN THE ARM WAS STILL NAVIGATED WITH A TOOL INSTALLED. THIS IS A KNOWN SOFTWARE ANOMALY THAT WAS ESCALATED AS A FIELD ACTION ZFA-2021-00198, FDA REFERENCE Z-0118-2022.

    Description of Event or Problem · 0

    ROBOT ARM COLLIDED AGAINST ROBOTIC BASE WHEN ORIENTING ITSELF FOR TRAJECTORY 5. ROBOT DID NOT PROMPT THE TRAJECTORY WAS INACCESSIBLE WITH THE MICRODRIVE HOLDER. ALL TRAJECTORIES WERE EDITED AFTER CONTACTLESS REGISTRATION. AFTER RESTARTING THE SYSTEM, CLINICAL REPRESENTATIVE (CR) WAS ABLE TO CLEAR THE ROBOTIC ARM. HOWEVER, AFTER THE SHUTDOWN, DURING THE VIGILANCE DEVICE ERROR MESSAGE, 'CLEAR ROBOT ARM' CHOICE PROMPTED AN EMPTY CALIBRATION. CR RECOGNIZED THIS AS THE SOFTWARE¿S FIELD ACTION EVENTS. TO CLEAR THE ROBOT, CR DROVE THE ROBOT HOME.

    Description of Event or Problem · 0

    ROBOT ARM COLLIDED AGAINST ROBOTIC BASE WHEN ORIENTING ITSELF FOR TRAJECTORY 5. ROBOT DID NOT PROMPT THE TRAJECTORY WAS INACCESSIBLE WITH THE MICRODRIVE HOLDER. ALL TRAJECTORIES WERE EDITED AFTER CONTACTLESS REGISTRATION. AFTER RESTARTING THE SYSTEM, CLINICAL REPRESENTATIVE (CR) WAS ABLE TO CLEAR THE ROBOTIC ARM. HOWEVER, AFTER THE SHUTDOWN, DURING THE VIGILANCE DEVICE ERROR MESSAGE, 'CLEAR ROBOT ARM' CHOICE PROMPTED AN EMPTY CALIBRATION. CR RECOGNIZED THIS AS THE SOFTWARE¿S FIELD ACTION EVENTS. TO CLEAR THE ROBOT, CR DROVE THE ROBOT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1063855 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