BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROSA ONE

    MDR report key: 8477006 · Received April 3, 2019

    Report

    Report Number
    3009185973-2019-00113
    Event Type
    Malfunction
    Date Received
    April 3, 2019
    Date of Event
    March 5, 2019
    Report Date
    February 28, 2020
    Manufacturer
    MEDTECH SA
    Product Code
    NAY
    PMA / PMN Number
    N/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

    CORRECTED DATA: - B4 DATE OF THIS REPORT. - G4 DATE RECEIVED BY MANUFACTURER. - H2 IF FOLLOW-UP, WHAT TYPE. - H6 EVENT PROBLEM AND EVALUATION CODES. - H10 ADDITIONAL NARRATIVES/DATA. H6_IT WAS NOTICED THAT THE CONCLUSION PROVIDED IN THE LAST MDR SENT REPORT WAS RELATED TO A DESIGN DEFECT WHILE THE ROOT CAUSE OF THE EVENT CAN NOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. FOR THIS REASON, IT WAS DECIDED TO SEND A FINAL REPORT IN ORDER TO MODIFY THE INFORMATION. TO REMIND THAT ACCORDING TO THE COMPLAINT DESCRIPTION, A COMMUNICATION ERROR OCCURRED AT THE BEGINNING OF A SPINAL SURGERY DUE TO A CORRUPTION OF THE FIRMWARE OF THE CAMERA. AFTER THE RE-INSTALLED OF THE CAMERA SOFTWARE, THE SYSTEM WAS FULLY FUNCTIONAL.

    Additional Manufacturer Narrative · 0

    UDI : (B)(4). CORRECTED DATA: - B4 DATE OF THIS REPORT - D4 UNIQUE IDENTIFIER (UDI) NUMBER - G4 DATE RECEIVED BY MANUFACTURER - H2 IF FOLLOW-UP, WHAT TYPE - H3 DEVICE EVALUATED BY MANUFACTURER - H6 EVENT PROBLEM AND EVALUATION CODES - H10 ADDITIONAL NARRATIVES/DATA ACCORDING TO THE COMPLAINT DESCRIPTION, A COMMUNICATION ERROR OCCURRED AT THE BEGINNING OF A SPINAL SURGERY DUE TO A CORRUPTION OF THE FIRMWARE OF THE CAMERA. AFTER THE RE-INSTALLED OF THE CAMERA SOFTWARE, THE SYSTEM WAS FULLY FUNCTIONAL. THE DEVICE MODEL ROSA ONE SPINE APPLICATION WAS NOT FDA CLEARED AT THE TIME OF THE EVENT BUT WAS SIMILAR TO THE DEVICE ROSA SPINE 1.0, CLASSIFIED OLO AND CLEARED UNDER K151511.

    Description of Event or Problem · 0

    THE FIELD SERVICE ENGINEER (FSE) WAS CONTACTED ON TUE. MARCH 5TH REGARDING A COMMUNICATION FAILURE WHICH HAPPENED ON ROSA ONE SPINE AT THE BEGINNING OF A SURGERY. THE SURGERY HAS BEEN PERFORMED WITH A 10-15MIN DELAY, WITH NAVIGATION. THE FSE WENT ON SITE ON TUESDAY EVENING TO TROUBLESHOOT THE SYSTEM, AND FOUND OUT THE CAMERA FIRMWARE WAS CORRUPTED, PREVENTING IT FROM WORKING. THE SYSTEM WAS FULLY FUNCTIONAL AFTER THE CAMERA SOFTWARE REINSTALLATION.

    Description of Event or Problem · 0

    THE FIELD SERVICE ENGINEER (FSE) WAS CONTACTED ON TUE. MARCH 5TH REGARDING A COMMUNICATION FAILURE WHICH HAPPENED ON ROSA ONE SPINE AT THE BEGINNING OF A SURGERY. THE SURGERY HAS BEEN PERFORMED WITH A 10-15MIN DELAY, WITH NAVIGATION. THE FSE WENT ON SITE ON TUESDAY EVENING TO TROUBLESHOOT THE SYSTEM, AND FOUND OUT THE CAMERA FIRMWARE WAS CORRUPTED, PREVENTING IT FROM WORKING. THE SYSTEM WAS FULLY FUNCTIONAL AFTER THE CAMERA SOFTWARE REINSTALLATION.

    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.  THE DEVICE MODEL ROSA ONE SPINE APPLICATION IS NOT FDA CLEARED BUT IS SIMILAR TO THE DEVICE ROSA SPINE 1.0, CLASSIFIED OLO AND CLEARED UNDER K151511.

    Description of Event or Problem · 1

    THE FIELD SERVICE ENGINEER (FSE) WAS CONTACTED ON TUE. MARCH 5TH REGARDING A COMMUNICATION FAILURE WHICH HAPPENED ON ROSA ONE SPINE AT THE BEGINNING OF A SURGERY. THE SURGERY HAS BEEN PERFORMED WITH A 10-15MIN DELAY, WITH NAVIGATION. THE FSE WENT ON SITE ON TUESDAY EVENING TO TROUBLESHOOT THE SYSTEM, AND FOUND OUT THE CAMERA FIRMWARE WAS CORRUPTED, PREVENTING IT FROM WORKING. THE SYSTEM WAS FULLY FUNCTIONAL AFTER THE CAMERA SOFTWARE REINSTALLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270460 ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE NAY MEDTECH SA ROSA ONE 3.1 3.1.0.1276

    Patients

    Seq Age Sex Outcome Treatment
    1