BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAL INTELLIGENCE CORI

    MDR report key: 16327175 · Received February 8, 2023

    Report

    Report Number
    3010266064-2023-00022
    Event Type
    Malfunction
    Date Received
    February 8, 2023
    Date of Event
    January 16, 2023
    Report Date
    March 21, 2023
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556757420
    PMA / PMN Number
    K193120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    H3, H6: THE REAL INTELLIGENCE CORI, PART NUMBER ROB10024, SERIAL NUMBER (B)(6), INTENDED FOR USE IN TREATMENT, WAS RETURNED FOR EVALUATION. THE REPORTED PROBLEM COULD NOT BE CONFIRMED WITH A VISUAL INSPECTION. THE REPORTED PROBLEM WAS CONFIRMED WITH A FUNCTIONAL EVALUATION. THE CONSOLE WOULD NOT BOOT AND THEN UNKNOWN NHM ERROR WAS OBSERVED. THE CORI CONSOLE WAS OPENED UP AND IT WAS FOUND THAT THE IRRIGATION PUMP MOTOR HAD BROKEN FREE FROM THE FRONT PANEL DUE TO ONE OF THE SCREWS HOLDING IT THERE BEING UNSEATED. THE MOTOR HAD UNPLUGGED ONE OF THE CONNECTIONS BETWEEN THE CPU AND TCU BOARDS. WHEN THE MOTOR WAS REMOVED AND THE CONNECTION REESTABLISHED, THE SOFTWARE AND IDB COULD BE INSTALLED AND THE SYSTEM BOOTS UP AS EXPECTED. A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE WAS ESTABLISHED. THE MOST LIKELY CAUSE OF THIS EVENT IS ONE OF THE SCREWS HOLDING THE MOTOR TO THE FRONT PANEL NOT BEING FULLY TIGHTENED AT SERVICE. 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. A HISTORICAL REVIEW CONCLUDED THAT NO PRIOR ESCALATION ACTIONS ARE APPLICABLE TO THE SCOPE OF THE REPORTED COMPLAINT. THE FAILURE MODE AND ASSOCIATED RISK HAVE BEEN ANTICIPATED WITHIN THE RISK FILE. THE RISK LEVEL IS STILL ADEQUATE. BASED ON THE INVESTIGATION, THE NEED FOR A CORRECTIVE ACTION IS NOT RECOMMENDED OR REQUIRED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED THE COMPLAINT WILL BE REOPENED. THE FAILURE MODE WILL CONTINUE TO BE CLOSELY MONITORED THROUGH COMPLAINT INVESTIGATION AND TRENDED THROUGH POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE INSTALLATION OPERATIONS THE NEW REAL INTELLIGENCE CORI WOULD NOT BOOT UP. RECEIVED NMH ERROR. TRIED TO UPLOAD SOFTWARE TWICE BUT GOT ERROR THAT FIRMWARE NOT ABLE TO INSTALL AND CANNOT OPEN PORT. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2211227 REAL INTELLIGENCE CORI ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES ROB10024 00885556757420

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown