BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAL INTELLIGENCE TRACKING CAMERA

    MDR report key: 11250286 · Received January 29, 2021

    Report

    Report Number
    3010266064-2021-00066
    Event Type
    Malfunction
    Date Received
    January 29, 2021
    Date of Event
    January 9, 2021
    Report Date
    October 26, 2021
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556757437
    PMA / PMN Number
    K193120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G3, H2, H3, AND H6: THE CORI CAMERA P/N ROB10025 S/N (B)(6) INTENDED FOR USE IN TREATMENT WAS RETURNED FOR EVALUATION. A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE WAS NOT ESTABLISHED. NOTHING VISUALLY CONTRIBUTED TO THE REPORTED PROBLEM. A FUNCTIONAL EVALUATION WAS PERFORMED. THE REPORTED PROBLEM WAS NOT CONFIRMED. A CAMERA ACCURACY VERIFICATION WAS PERFORMED AND PASSED. THE CAMERA FUNCTIONED AS INTENDED WITHOUT ANY ERRORS. 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, A CONTRIBUTING FACTOR MAY BE A LOOSE CABLE CONNECTION. ALTHOUGH NO FURTHER CONTAINMENT OR CORRECTIVE ACTION IS RECOMMENDED OR REQUIRED AT THIS TIME, ALL COMPLAINTS ARE MONITORED AND TRENDED THROUGH POST MARKET SURVEILLANCE ACTIVITIES. D8 AND D9: UPDATED PART NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, BEFORE A CORI LAB, THE CASE WAS SET UP AND AWAITING TRACKER POSITIONING. AN AUDIBLE BEEP WAS HEARD AND A MESSAGE APPEARED THAT CAMERA CONNECTION WAS LOST. A SECONDARY MESSAGE APPEARED THAT THE UNIT WAS TRYING TO REESTABLISH CONNECTION WITH A SPINNING WHEEL. THEY WAITED 5 MINUTES APPROXIMATELY AND UNPLUGGED THE PROVIDED ETHERNET CABLE FROM DEMO UNIT AND CAMERA AND REATTACHED. THEY DID A HARD RESET AND STARTED A NEW CASE AND PROCEEDED WITH NO FURTHER ISSUE. NO PATIENT WAS INVOLVED. NO OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150934 REAL INTELLIGENCE TRACKING CAMERA ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES ROB10025 00885556757437

    Patients

    Seq Age Sex Outcome Treatment
    1 CORI ROBOTICS USA/ (B)(6)