BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSA ONE

    MDR report key: 7572451 · Received June 6, 2018

    Report

    Report Number
    3009185973-2018-00168
    Event Type
    Injury
    Date Received
    June 6, 2018
    Date of Event
    June 4, 2018
    Report Date
    January 31, 2019
    Manufacturer
    MEDTECH SA
    Product Code
    HAW
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO LOAD PATIENT FOLDER FROM LAPTOP TO ROBOT PC. A DHR REVIEW AND A COMPLAINT HISTORY REVIEW WERE PERFORMED AND DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. ANALYSIS OF DATA LOGS COULD ALLOW TO DETERMINE THE CAUSE OF THE ISSUE HOWEVER THIS ANALYSIS REQUIRES ORIGINAL PATIENT FOLDER WHICH IS NOT AVAILABLE. ACCORDING TO THE COMPLAINT DESCRIPTION THE FSE STATES THAT THE CAUSE OF THE ISSUE IS A DIFFERENCE OF OPTIONS INSTALLED ON THE LAPTOP AND ON THE ROBOT PC. IT IS NOTED THAT THE FSE HELPED TO RESOLVE THE ISSUE BY PHONE, MODIFYING THE PATIENT FOLDER LICENSES AND CRC CODE THEREFORE THE CAUSE OF THE ISSUE CAN BE CONFIRMED. PATIENT CODE 3191 - NO CODE AVAILABLE : DELAY GREATER THAN 30 MINUTES ON THE SURGERY DUE TO THIS EVENT. 4316 - APPROPRIATE TERM/CODE NOT AVAILABLE : DIFFERENT OPTIONS INSTALLED ON THE LAPTOP AND THE ROBOT PC.

    Description of Event or Problem · 0

    THE SURGEON DIDN'T MANAGE TO TRANSFER PATIENT FOLDER FROM THE PLANNING STATION TO ROSA DEVICE WITH HER USB FLASHDRIVE. A MESSAGE APPEARED: "IMPOSSIBLE TO LOAD EXAM". THE PATIENT WAS UNDER ANAESTHESIA. THE FIELD SERVICE ENGINEER HELP THE DOCTOR BY PHONE: RETRIEVAL OF THE LICENCE ON A FORMER PATIENT FOLDER AND REPLACEMENT OF THE LICENCE IN .ROS OF THE NEW PATIENT FOLDER WHERE THE LICENCE WAS DIFFERENT. REGENERATION OF THE CRC CODE. THE PROBLEM WAS SOLVED.

    Additional Manufacturer Narrative · 1

    THE DEVICE MODEL ROSA ONE IS NOT FDA CLEARED BUT IS SIMILAR TO THE DEVICE ROSA BRAIN 3.0, CLASSIFIED HAW AND CLEARED UNDER K151359. THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION WILL BE PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. NO CODE AVAILABLE' WAS SELECTED AS THERE WAS A DELAY GREATER THAN 30 MINUTES ON THE SURGERY DUE TO THIS EVENT.

    Description of Event or Problem · 1

    THE SURGEON DIDN'T MANAGE TO TRANSFER PATIENT FOLDER FROM THE PLANNING STATION TO ROSA DEVICE WITH HER USB FLASHDRIVE. A MESSAGE APPEARED: "IMPOSSIBLE TO LOAD EXAM". THE PATIENT WAS UNDER ANAESTHESIA. THE FIELD SERVICE ENGINEER HELP THE DOCTOR BY PHONE: RETRIEVAL OF THE LICENCE ON A FORMER PATIENT FOLDER AND REPLACEMENT OF THE LICENCE IN .ROS OF THE NEW PATIENT FOLDER WHERE THE LICENCE WAS DIFFERENT. REGENERATION OF THE CRC CODE. THE PROBLEM WAS SOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417573 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA ROSA ONE SOFTWARE 3.1.0.1276

    Patients

    Seq Age Sex Outcome Treatment
    1