BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 11371837 · Received February 24, 2021

    Report

    Report Number
    3009185973-2021-00063
    Event Type
    Malfunction
    Date Received
    February 24, 2021
    Date of Event
    February 12, 2021
    Report Date
    November 23, 2021
    Manufacturer
    MEDTECH SA
    Product Code
    OLO
    PMA / PMN Number
    K192173
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND THIS ANALYSIS CONCLUDED THAT : THE ARM FAILED TO CONNECT TWICE DUE TO A COMMUNICATION FAILURE BETWEEN THE ROBOTIC SOFTWARE AND THE ROBOT ARM CONTROLLER. THIS ISSUE WILL BE ADDRESSED THROUGH THE CONTINUOUS IMPROVEMENT PROCESS OF OUR PRODUCTS. TWO SOFTWARE UNEXPECTED INTERRUPTION WERE DETECTED AND REQUIRED SOFTWARE RESTART. ONE WAS DUE TO A SYSTEM FREEZE AND THE OTHER DUE TO THE APPLICATION SOFTWARE FREEZE. THE CAUSE FOR THOSE ERRORS CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    THE CLINICAL REPRESENTATIVE (CR) WAS IN UNIVERSITY FRANKFURT FOR THE SPINE APPLICATIVE TRAINING. WHEN START THE ROSA ROBOT, THE SYSTEM BROUGHT UP AN ROBOTIC ERROR. SYSTEM HAD TO BE SHUT DOWN. THE CR POWERED THE SYSTEM OF FOR ABOUT 60 SECS. THE NEXT START WAS SUCCESSFUL. THE CR WENT THROUGH THE SETUP PROCEDURE AND THE ZIEHM IMAGING SYSTEM TOLD HE IS READY FOR THE SCAN. THE CR STARTED THE COUNTDOWN FOR IMAGE AQUISITION. THE ZIEHM BROUGHT UP A COLLISION WARNING. THE ZIEHM AND TABLE HAD TO BE REPOSITIONED. THE CR TRIED TO ABORT IMAGE TRANSFER, BUT SYSTEM FROZE AND HAD TO BE RESTARTED. AFTER RESTART, SYSTEM WHEN THROUGH ROBOT CAMERA REGISTRATION AGAIN, WHICH HAD BEEN DONE SUCCESSFUL BEFORE. NEXT ATTEMPT TRANFER WORKED.

    Additional Manufacturer Narrative · 1

    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).

    Description of Event or Problem · 1

    THE CLINICAL REPRESENTATIVE (CR) WAS IN (B)(6) FOR THE SPINE APPLICATIVE TRAINING. WHEN START THE ROSA ROBOT, THE SYSTEM BROUGHT UP AN ROBOTIC ERROR. SYSTEM HAD TO BE SHUT DOWN. THE CR POWERED THE SYSTEM OF FOR ABOUT 60 SECS. THE NEXT START WAS SUCCESSFUL. THE CR WENT THROUGH THE SETUP PROCEDURE AND THE ZIEHM IMAGING SYSTEM TOLD HE IS READY FOR THE SCAN. THE CR STARTED THE COUNTDOWN FOR IMAGE ACQUISITION. THE ZIEHM BROUGHT UP A COLLISION WARNING. THE ZIEHM AND TABLE HAD TO BE REPOSITIONED. THE CR TRIED TO ABORT IMAGE TRANSFER, BUT SYSTEM FROZE AND HAD TO BE RESTARTED. AFTER RESTART, SYSTEM WHEN THROUGH ROBOT CAMERA REGISTRATION AGAIN, WHICH HAD BEEN DONE SUCCESSFUL BEFORE. NEXT ATTEMPT TRANSFER WORKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269302 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE OLO MEDTECH SA ROSA ONE 3.1 3.1.4.1650

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown