BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAL INTELLIGENCE CORI

    MDR report key: 10667490 · Received October 12, 2020

    Report

    Report Number
    3010266064-2020-01853
    Event Type
    Malfunction
    Date Received
    October 12, 2020
    Date of Event
    September 16, 2020
    Report Date
    July 16, 2021
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556757420
    PMA / PMN Number
    K191223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H6: THE REAL INTELLIGENCE CORI, PN: ROB10024, SN: (B)(6) USED FOR TREATMENT WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR EVALUATION, AND THE CORI LOG FILES AND/OR CASE FILES WERE NOT PROVIDED. THEREFORE VISUAL AND FUNCTIONAL INSPECTIONS AND LOG/CASE FILE ASSESSMENTS COULD NOT BE PERFORMED, AND THE REPORTED PROBLEM COULD NOT BE CONFIRMED. A REVIEW OF MANUFACTURING RECORDS INDICATE THE SOFTWARE MET ALL SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTS, THIS ISSUE WILL CONTINUE TO BE MONITORED. ALTHOUGH THE REPORTED PROBLEM COULD NOT BE CONFIRMED, A CONTRIBUTING FACTOR TO THE REPEATED ERROR WHERE THE TIBIA KNEE CENTER IS PROXIMAL TO THE FEMUR KNEE CENTER WHILE COLLECTING NEUTRAL POSITION COULD BE THAT THE TIBIA KNEE CENTER WAS COLLECTED TOO CLOSE TO THE FEMUR KNEE CENTER. REFER TO THE REAL INTELLIGNECE CORI FOR KNEE ARTHROPLASTY USER MANUAL WHEN INCURRING WARNING MESSAGES. WHEN THIS ERROR OCCURS FOR A TKA CASE, PRESS THE 'OK' BUTTON, AND RE-COLLECT THE POINTS. THE KNEE CENTER IS THE GEOMETRIC CENTER OF THE TIBIA, LOCATED IN THE MIDDLE OF THE FOOTPRINT OF THE ACL BUNDLE. PLACE THE POINT PROBE ON THE KNEE CENTER POINT OF THE TIBIA. PRESS THE RIGHT FOOT PEDAL TO COLLECT THE POINT. PLACE THE POINT PROBE AT THE CENTER OF THE FEMORAL ARTICULATING SURFACE FOR THE FEMUR KNEE CENTER POINT. PRESS THE RIGHT FOOT PEDAL TO COLLECT THE POINT. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. IF THE SYSTEM LOG OR CASE LOG ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS EVALUATION WILL BE REOPENED FOR INVESTIGATION. D9: DEVICE REURNED D4: UPDATE SERIAL NUMBER D10: ADD CONCOMITNATNS G1: UPDATE CONTACT NAME AND ADDRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORI TKA PROCEDURE, AN ERROR CAME UP WHERE IT SAID THAT THE TIBIA KNEE CENTER IS PROXIMAL TO FEMUR KNEE CENTER WHILE COLLECTING NEUTRAL POSITION. THEY HAD TO RECOLLECT THREE TIMES BEFORE IT WAS ACCEPTED. THE FOOT PEDAL WASN¿T WORKING AND HAD TO BE UNPLUGGED AND RE-PLUGGED IN. THEY HELD DOWN BUTTONS TO COLLECT POINTS AND IT WORKED AGAIN. NO OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1130997 REAL INTELLIGENCE CORI ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES ROB10024 UNKNOWN 00885556757420

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CORI ROBOTICS USA/ROB20000/(B)(6).