BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAL INTELLIGENCE CORI

    MDR report key: 16432395 · Received February 23, 2023

    Report

    Report Number
    3010266064-2023-00031
    Event Type
    Malfunction
    Date Received
    February 23, 2023
    Date of Event
    January 31, 2023
    Report Date
    March 31, 2023
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556757420
    PMA / PMN Number
    K193120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: THE REAL INTELLIGENCE CORI, PART NUMBER ROB10024, SERIAL NUMBER (B)(6), INTENDED FOR TREATMENT WAS RETURNED FOR EVALUATION. THE REPORTED PROBLEM COULD NOT BE CONFIRMED WITH A VISUAL INSPECTION. THE REPORTED PROBLEM WAS NOT CONFIRMED WITH A FUNCTIONAL EVALUATION. THE CONSOLE WAS TESTED WITH DRILL, MONITOR AND TABLET. THE REPORTED PROBLEM WAS CONFIRMED WITH A LOG FILE REVIEW. LOG FILES HAVE BEEN EXPORTED AND UPLOADED TO OUR COMPLAINT FOLDER. THE CRITICAL ERROR WAS VISIBLE IN THE LOG FILE REVIEW. THE REVIEW CONCLUDED TWO REASONS. ONE, THE DATABASE HAS ONE OR MORE RECORDS THAT ARE CORRUPT. TWO, THIS IS AN INSTANCE OF BUG 2121 WHERE THE SYSTEM DISPLAYS A CRITICAL ERROR WHEN TRANSITIONING FROM THE PATIENT INFORMATION SCREEN TO THE ADMIN SCREEN. A COMPLAINT HISTORY REVIEW FOR SIMILAR REPORTED/CONFIRMED COMPLAINTS HAS IDENTIFIED PRIOR EVENTS. A REVIEW OF MANUFACTURING RECORDS INDICATE THE DEVICE MET ALL SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. THE FAILURE MODE AND ASSOCIATED RISK HAVE BEEN ANTICIPATED WITHIN THE RISK FILE AND THE DOCUMENTED RISK LEVEL IS STILL WITHIN THE PRODUCT RISK PROFILE. A HISTORICAL REVIEW CONCLUDED THAT NO PRIOR ESCALATION ACTIONS ARE APPLICABLE TO THE SCOPE OF THE REPORTED COMPLAINT. THE MOST LIKELY CAUSE OF THIS EVENT IS ASSOCIATED WITH A SOFTWARE CONSOLE BUG AND POSSIBLY A CORRUPT DATABASE. BASED ON THE INVESTIGATION, NO CONTAINMENT OR CORRECTIVE ACTION IS 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. INTERNAL COMPLAINT REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REAL INTELLIGENCE CORI SHOWED A "CRITICAL ERROR" AND THE SYSTEM SHUTS DOWN. THE DRILLS WERE REPLACED (IN ONE A CONNECTION PROBLEM WAS SUSPECTED, THE OTHER FAILED KCP TEST), HOWEVER THE PROBLEM PERSISTED. IN ADDITION, THE SOFTWARE WAS REINSTALLED FROM TWO DIFFERENT USB STICKS BUT THE "CRITICAL ERROR" STILL POPS UP AND THE SYSTEM SHUTS DOWN. IT IS NOT KNOWN SPECIFICALLY AT WHAT STAGE OF THE SURGERY THE INCIDENT OCCURRED, SO THE INVOLVEMENT OF THE PATIENT HAS NOT BEEN CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448880 REAL INTELLIGENCE CORI ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES ROB10024 00885556757420

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown