BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 10338142 · Received July 29, 2020

    Report

    Report Number
    3009185973-2020-00183
    Event Type
    Malfunction
    Date Received
    July 29, 2020
    Date of Event
    July 7, 2020
    Report Date
    November 16, 2020
    Manufacturer
    MEDTECH SA
    Product Code
    HAW
    PMA / PMN Number
    K182417
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND THIS ANALYSIS CONCLUDED THAT THE REGISTRATION FAILED BECAUSE THE SCAN WAS INTERRUPTED BY A TIMEOUT ERROR. THE DEVICE DETECTED THAT THE SCAN LOOP LASTED OVER THE THRESHOLD LIMIT AND THAT AN ERROR OCCURRED IN THE CONTROLLER, WHICH PROVOKED THE DEVICE SHUTDOWN. HOWEVER, THE ANALYSIS OF THE CONTROLLER LOG DID NOT PERMIT TO IDENTIFY THIS ERROR AND DETERMINE WHETHER IT TRIGGERED THE ISSUE; THEREFORE THE TECHNICAL ROOT CAUSE OF THE EVENT REMAINS UNDETERMINED. HOWEVER THE DEVICE BEHAVED AS EXPECTED AND AS SPECIFIED, AS THE ERROR DETECTED IN THE CONTROLLER PROVOKED THE SHUTDOWN OF THE DEVICE.

    Description of Event or Problem · 0

    UNABLE TO COMPUTE REGISTRATION FROM MRI, THE FIELD SERVICE ENGINEER EXPLAINED THAT CT WAS BEST FOR CONTACTLESS REGISTRATION, BUT SURGEON WANTED TO PROCEED. SURGEON FEEDBACK PROVIDED THAT THERE SHOULD BE AN OPTION TO CALCULATE OR ESTIMATE IS THE 3D RECONSTRUCTION IS SUFFICIENT FOR REGISTRATION BASED OFF IMAGE QUALITY, AND WHEN REGISTRATION FAILS IT SHOULD SHOW THE POINTS THAT ARE FAILING.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    UNABLE TO COMPUTE REGISTRATION FROM MRI, THE FIELD SERVICE ENGINEER EXPLAINED THAT CT WAS BEST FOR CONTACTLESS REGISTRATION, BUT SURGEON WANTED TO PROCEED. SURGEON FEEDBACK PROVIDED THAT THERE SHOULD BE AN OPTION TO CALCULATE OR ESTIMATE IS THE 3D RECONSTRUCTION IS SUFFICIENT FOR REGISTRATION BASED OFF IMAGE QUALITY, AND WHEN REGISTRATION FAILS IT SHOULD SHOW THE POINTS THAT ARE FAILING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805876 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE HAW MEDTECH SA ROSA ONE 3.1.1.1295

    Patients

    Seq Age Sex Outcome Treatment
    1