BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 11371747 · Received February 24, 2021

    Report

    Report Number
    3009185973-2021-00059
    Event Type
    Malfunction
    Date Received
    February 24, 2021
    Date of Event
    February 3, 2021
    Report Date
    April 29, 2021
    Manufacturer
    MEDTECH SA
    Product Code
    HAW
    PMA / PMN Number
    K200511
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND CONCLUDED THAT THE BLANK POPUP AND FREEZE WERE DUE TO THE OVERLAPPING OF TWO COMMANDS, A COOPERATIVE SLOW MODE AND AN AUTOMATIC MOVEMENT. THIS IS DUE TO A KNOWN SOFTWARE ANOMALY WHICH WILL BE ADDRESSED THROUGH OUR CONTINUOUS IMPROVEMENT PROCESS.

    Description of Event or Problem · 0

    BLANK SCREEN DISPLAYED, WHEN MOVEMENT IN PROGRESS SCREEN SHOULD HAVE BEEN DISPLAYED, COMPANY REPRESENTATIVE UNABLE TO GET SOFTWARE TO RESPOND, REQUIRED COMPANY REPRESENTATIVE TO HIT EMERGENCY STOP BUTTON TO RESTART SOFTWARE AND RECONNECT TO CONTROLLER. DELAY OF 5 MINUTES.

    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

    BLANK SCREEN DISPLAYED, WHEN MOVEMENT IN PROGRESS SCREEN SHOULD HAVE BEEN DISPLAYED, COMPANY REPRESENTATIVE UNABLE TO GET SOFTWARE TO RESPOND, REQUIRED COMPANY REPRESENTATIVE TO HIT EMERGENCY STOP BUTTON TO RESTART SOFTWARE AND RECONNECT TO CONTROLLER. DELAY OF 5 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271600 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA ROSA ONE 3.1.4.1650

    Patients

    Seq Age Sex Outcome Treatment
    1