BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 7513531 · Received May 15, 2018

    Report

    Report Number
    3009185973-2018-00145
    Event Type
    Malfunction
    Date Received
    May 15, 2018
    Date of Event
    April 27, 2018
    Report Date
    August 21, 2018
    Manufacturer
    MEDTECH SA
    Product Code
    HAW
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE SURGEON NEEDED TO RE-DO THE PLANNING ON THE ROSA PC BECAUSE HE COULD NOT LOAD THE PATIENT DATA PREVIOUSLY EXPORTED FROM THE PLANNING STATION. A DHR REVIEW AND A COMPLAINT HISTORY REVIEW WERE PERFORMED AND DID IDENTIFY 1 SIMILAR COMPLAINT WHICH HAD OCCURRED ONE WEEK BEFORE. A FULL ANALYSIS OF DATA LOG HAS BEEN PERFORMED AND INDICATES THAT THE CAUSE OF THE ISSUE IS A DISCREPANCY BETWEEN OPTIONS INSTALLED ON THE ROSA PC AND THE COMPUTER FOR PRE-OP PLANNING. BASED ON THE TECHNICAL INVESTIGATION PERFORMED THE ROOT CAUSE IDENTIFIED IS A MANUFACTURING NON-CONFORMITY WHICH IS BEING FURTHER INVESTIGATED INTERNALLY. UNIQUE IDENTIFIER (UDI)#: (B)(4). CORRECTED DATA: DATE OF THIS REPORT. DATE RECEIVED BY MANUFACTURER. IF FOLLOW-UP, WHAT TYPE. DEVICE EVALUATED BY MANUFACTURER. EVALUATION CODE.

    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/K172444. THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION WILL BE PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ROBOT WAS UNABLE TO LOAD THE PATIENT DATA JUST BEFORE A SURGERY. THIS DATA WAS PREVIOUSLY EXPORTED FROM THE COMPUTER FOR PRE-OP PLANNING. CONSEQUENTLY, THE SURGERY PLANNING HAD TO BE REDONE ON THE ROBOT. THERE WAS A REPORTED DELAY OF ABOUT 10 MINUTES TO REDO THE PLANNING AND RESTART THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356462 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA ROSA ONE 3.1.0.1276

    Patients

    Seq Age Sex Outcome Treatment
    1