BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 7751196 · Received August 6, 2018

    Report

    Report Number
    3009185973-2018-00214
    Event Type
    Malfunction
    Date Received
    August 6, 2018
    Date of Event
    April 20, 2018
    Report Date
    November 8, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE SURGEON WAS NOT ABLE TO LOAD THE PATIENT FOLDER IN THE ROBOT. A DHR REVIEW AND A COMPLAINT HISTORY REVIEW WERE PERFORMED AND DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. TECHNICAL INVESTIGATION CONCLUDED THAT THE CAUSE OF THE ISSUE IS A DISCREPANCY BETWEEN OPTIONS INSTALLED ON THE ROSA ONE PC AND THE LAPTOP. BASED ON THE TECHNICAL INVESTIGATION PERFORMED THE ROOT CAUSE IDENTIFIED IS A MANUFACTURING NON-CONFORMITY. THE DEVICE MODEL ROSA ONE IS NOT FDA CLEARED BUT IS SIMILAR TO THE DEVICE ROSA BRAIN 3.0, CLASSIFIED HAW AND CLEARED UNDER K172444. (B)(4).

    Description of Event or Problem · 0

    ON THE (B)(6) 2018, DURING AN ASSISTED SURGERY THE PLANNING PERFORMED ON THE PLANNING STATION COULD NOT BE LOADED INTO THE ROSA ONE PC. IT IS AT THIS TIME THAT CST AND SURGEON NOTICED THAT THERE WAS A DISCREPANCY BETWEEN LICENSES INSTALLED ON THE PLANNING STATION AND ON THE ROBOT. THE CST MODIFIED MANUALLY THE PATIENT FOLDER SO THAT IT COULD BE USED AND OPENED ON THE OR ON THE ROBOT PC.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION WILL BE PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY THE PATIENT FOLDER COULD NOT BE LOADED ON THE ROBOT PC FROM THE PLANNING STATION AS THE PLANNING STATION AND THE ROBOT PC HAVE DIFFERENT LICENSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592423 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA ROSA ONE 3.1 3.1.0.1276

    Patients

    Seq Age Sex Outcome Treatment
    1