BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAL INTELLIGENCE CORI

    MDR report key: 14214404 · Received April 26, 2022

    Report

    Report Number
    3010266064-2022-00323
    Event Type
    Malfunction
    Date Received
    April 26, 2022
    Date of Event
    March 31, 2022
    Report Date
    July 11, 2022
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556757420
    PMA / PMN Number
    K193120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    H3, H6: THE CORI CONSOLE, PN ROB10024, (B)(6) , INTENDED FOR USE IN TREATMENT, WAS RETURNED FOR EVALUATION. A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE WAS ESTABLISHED. THE REPORTED EVENT WAS CONFIRMED VISUALLY AND FUNCTIONALITY. TWO CABLES IN THE DRILL PORT LOCATED INTERNALLY IN THE CONSOLE ARE DETACHED. THIS CAUSED THE DRILL TO FAILED. WHEN THE DRILL WAS BEEN TESTED, IN THE ADMINISTRATOR SCREEN, THE MESSAGE DRILL CRITICAL ERROR WAS OBSERVED. WHEN A CASE WAS TRY, TIME OUT ERROR OCCURRED AND THE DRILL CONSOLE INDICATOR STARTED TO BLINK. THE MOST LIKELY CAUSED OF THIS EVENT IS THE WIRING DETACHMENT CAUSED THE CONSOLE TO NOT BE ABLE TO CONNECT WITH THE DRILL. THE SYSTEM READ A COMMUNICATION ERROR, AND THINK IT IS THE DRILL THE ONE THAT IS WORKING INCORRECTLY. 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 ESCALATION EVENT REVIEW WAS COMPLETED. A REVIEW OF PRIOR ESCALATION ACTIONS FOUND NO ACTIONS APPLICABLE TO THE SCOPE OF THIS CASE. THE FAILURE MODE AND ASSOCIATED RISK HAVE BEEN ANTICIPATED WITHIN THE RISK FILE AND THE DOCUMENTED RISK LEVEL IS STILL ADEQUATE. ALTHOUGH NO FURTHER CONTAINMENT OR CORRECTIVE ACTION IS RECOMMENDED OR REQUIRED AT THIS TIME, ALL COMPLAINTS ARE MONITORED THROUGH COMPLAINT INVESTIGATION AND POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING TESTING OF THE EQUIPMENT FOR A CORI ASSISTED LAB/DEMO, A SYSTEM FAULT COMMUNICATION ERROR APPEARED AT THE BUR LOADING STEP. AN INTERNAL ERROR MESSAGE APPEARED, AND AFTER THE OK BUTTON WAS SELECTED, THE BUTTONS ON THE SCREEN WERE FADED IN COLOR AND BECAME INACTIVE. THE CORI CONSOLE HAD TO BE REBOOTED. DIFFERENT ROBOTIC DRILLS WERE TRIED BUT THE ISSUE REMAINED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1513872 REAL INTELLIGENCE CORI ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES ROB10024 00885556757420

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown