BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 7356968 · Received March 21, 2018

    Report

    Report Number
    3009185973-2018-00087
    Event Type
    Malfunction
    Date Received
    March 21, 2018
    Date of Event
    March 14, 2018
    Report Date
    July 11, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INVESTIGATION PERFORMED ON MANUFACTURING RECORDS AND QMS FILE, THE TECHNICAL ROOT CAUSE OF THE EVENT WAS FOUND TO BE RELATED TO A NON CONFORMITY. THE NON CONFORMITY HAS BEEN OPEN FOLLOWING THE IDENTIFICATION OF 2 EMPTY AND UNUSABLE FILES ON THE QA&RA SERVER THAT CAUSED AN EMPTY LIST OF NAVIGATED INSTRUMENTS AND REFERENCES AND THE IMPOSSIBILITY TO GENERATE THE FILE .DEF. THE NON COFORMITY IS STILL IN PROGRESS. CORRECTED DATA: DATE OF THIS REPORT, MANUFACTURER EMAIL, OCCUPATION, OFFICE CONTACT, DATE RECEIVED BY MANUFACTURER, IF FOLLOW-UP, WHAT TYPE, DEVICE EVALUATED BY MANUFACTURER, DEVICE MANUFACTURE DATE, EVALUATION CODE.

    Additional Manufacturer Narrative · 1

    THE DEVICE ROSA ONE (B)(4) IS NOT FDA APPROVED, BUT IT IS SIMILAR TO THE DEVICE ROSA BRAIN 3.0, CLASSIFIED (B)(4) THE DEVICE (B)(4) 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 A FILE USED TO ENABLE USER TO USE SAVED-NAVIGATED LENGTH FOR INSTRUMENTS WAS NOT PRESENT IN THE NEW COMPUTER INSTALLED IN THE DEVICE. THE FIELD SERVICE ENGINEER RE-INSTALLED THE FILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203395 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA WORKSTATION 3.1.0.1276

    Patients

    Seq Age Sex Outcome Treatment
    1