BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 7221187 · Received January 26, 2018

    Report

    Report Number
    3009185973-2018-00034
    Event Type
    Malfunction
    Date Received
    January 26, 2018
    Date of Event
    January 22, 2018
    Report Date
    March 23, 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
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO COMPLAINT DESCRIPTION, THERE IS AN ISSUE TO REFRESH DISPLAYING OF TRACKING STATUS. IT IS A KNOWN DESIGN DEFECT. 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 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, SERIAL (B)(4), IS NOT FDA CLEARED BUT IS SIMILAR TO THE DEVICE ROSA BRAIN 3.0, CLASSIFIED HAW AND CLEARED UNDER K151359.

    Description of Event or Problem · 1

    DURING A SPINE SURGERY, THE SURGEON WORKED BETWEEN THE CAMERA STAND AND THE PATIENT REFERENCE WHICH GENERATED A NORMAL MESSAGE ON THE SCREEN INDICATING THAT THE TRACKING WAS LOST. HOWEVER, THIS MESSAGE WAS DISPLAYED ONLY ON 3 OF THE 4 CLINICAL VIEWS VISIBLE ON THE SCREEN. ON THE 4TH ONE IT WAS STILL INDICATED THE MESSAGE "TRACKING IS ON" DURING SEVERAL SECONDS BEFORE CHANGING TO THE CORRECT MESSAGE "TRACKING LOST". THIS OCCURRED MULTIPLE TIMES DURING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66574 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA ROSA ONE 3.1 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1