BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAL INTELLIGENCE CORI

    MDR report key: 11113534 · Received January 4, 2021

    Report

    Report Number
    3010266064-2021-00003
    Event Type
    Malfunction
    Date Received
    January 4, 2021
    Date of Event
    December 14, 2020
    Report Date
    October 27, 2021
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556757420
    PMA / PMN Number
    K193120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE CORI CONSOLE P/N ROB10024 (B)(6) INTENDED FOR USE IN TREATMENT WAS RETURNED. NOTHING WAS IDENTIFIED VISUALLY THAT CONTRIBUTED TO THE REPORTED PROBLEM. AN ASSESSMENT OF LOG FILES COULD NOT BE COMPLETED BECAUSE THE APPROPRIATE LOG FILES WERE NOT ATTACHED. A FUNCTIONAL EVALUATION WAS PERFORMED. A KPC TEST WAS PERFORMED AND THE TEST PASSED. THE REPORTED PROBLEM WAS CONFIRMED. AN "INTERNAL ERROR" WAS PRESENTED DURING FEMUR POINT COLLECTION. A REVIEW OF MANUFACTURING AND SERVICE RECORDS INDICATE THE DEVICE MET ALL SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOR SIMILAR REPORTED/CONFIRMED COMPLAINTS HAS IDENTIFIED PRIOR EVENTS. ALTHOUGH THE REPORTED PROBLEM WAS NOT CONFIRMED, NO REASONABLE CONTRIBUTING FACTORS COULD BE IDENTIFIED BASED ON THE RECEIVED COMPLAINT INFORMATION AND INVESTIGATION RESULTS. FURTHER INVESTIGATION INTO THE REPORTED FAILURE IS BEING CONDUCTING TO DETERMINE IF ADDITIONAL ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 0

    H3, H6: THE CORI CONSOLE P/N ROB10024 SN(B)(6) INTENDED FOR USE IN TREATMENT WAS RETURNED. NOTHING WAS IDENTIFIED VISUALLY THAT CONTRIBUTED TO THE REPORTED PROBLEM. AN ASSESSMENT OF LOG FILES COULD NOT BE COMPLETED BECAUSE THE APPROPRIATE LOG FILES WERE NOT ATTACHED. A FUNCTIONAL EVALUATION WAS PERFORMED. A KPC TEST WAS PERFORMED AND THE TEST PASSED. THE REPORTED PROBLEM WAS CONFIRMED. AN "INTERNAL ERROR" WAS PRESENTED DURING FEMUR POINT COLLECTION. A REVIEW OF MANUFACTURING AND SERVICE RECORDS INDICATE THE DEVICE MET ALL SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOR SIMILAR REPORTED/CONFIRMED COMPLAINTS HAS IDENTIFIED PRIOR EVENTS. ALTHOUGH THE REPORTED PROBLEM WAS NOT CONFIRMED, NO REASONABLE CONTRIBUTING FACTORS COULD BE IDENTIFIED BASED ON THE RECEIVED COMPLAINT INFORMATION AND INVESTIGATION RESULTS. FURTHER INVESTIGATION INTO THE REPORTED FAILURE IS BEING CONDUCTING TO DETERMINE IF ADDITIONAL ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER UPGRADING BOTH THE CONSOLE AND THE SOFTWARE DURING A CORI TEST SAW BONE LAB/DEMO, THE START UP SEEMED TO BE PERFECTLY FINE. HOWEVER, THEY RECEIVED AN INTERNAL ERROR DURING THE CHECKPOINT VERIFICATION PHASE OF THE FEMUR: WHEN THEY WENT TO COLLECT THE FEMUR CHECKPOINT TO VERIFY. AS SOON AS THEY COLLECTED THE POINT, THE SCREEN ON THE 24 INCH MONITOR WENT BLACK AND WHEN IT CAME BACK ON, THE SCREEN PRESENTED AN INTERNAL ERROR ON THE CASE INFORMATION SCREEN. THIS BROUGHT THEM BACK TO THE BUR OPTION SCREEN AND THEY WERE ABLE TO PROCEED. NO PATIENT WAS INVOLVED. NO OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5011 REAL INTELLIGENCE CORI ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES ROB10024 00885556757420

    Patients

    Seq Age Sex Outcome Treatment
    1