BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAL INTELLIGENCE CORI

    MDR report key: 12203448 · Received July 21, 2021

    Report

    Report Number
    3010266064-2021-00562
    Event Type
    Malfunction
    Date Received
    July 21, 2021
    Date of Event
    July 9, 2021
    Report Date
    November 3, 2022
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556757420
    PMA / PMN Number
    K193120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE REAL INTELLIGENCE CORI, PART NUMBER ROB10024, SERIAL NUMBER SN(B)(6), INTENDED FOR TREATMENT WAS NOT RETURNED FOR EVALUATION. AN IMAGE WAS PROVIDED. A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE WAS ESTABLISHED. THE REPORTED PROBLEM WAS CONFIRMED WITH A VISUAL INSPECTION. THE IMAGE PROVIDED CONFIRMED THE CRITICAL ERROR DISPLAYED. 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. THE RISK LEVEL IS STILL ADEQUATE. 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 BUG. 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 · 1

    IT WAS REPORTED THAT, DURING A TEST PRIOR A CORI-LAB, A CRITICAL ERROR WAS DISPLAYED AFTER QUITTING OUT OF PASSED DRILL DIAGNOSTICS. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101657 REAL INTELLIGENCE CORI ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES ROB10024 00885556757420

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown