BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAL INTELLIGENCE CORI

    MDR report key: 12044167 · Received June 22, 2021

    Report

    Report Number
    3010266064-2021-00475
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Date of Event
    June 5, 2021
    Report Date
    September 12, 2022
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556757420
    PMA / PMN Number
    K193120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAL INTELLIGENCE CORI, PN: ROB10024, SN: (B)(6) USED FOR TREATMENT WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR EVALUATION, THEREFORE VISUAL AND FUNCTIONAL INSPECTIONS COULD NOT BE PERFORMED. THE LOG FILES SUBMITTED WERE INVALID AND COULD NOT BE REVIEWED. THEREFORE, THE REPORTED POST-OP BASELINE COLLECTION ISSUES COULD NOT BE CONFIRMED. BASED ON THE REPORTED COMPLAINT, A POSSIBLE CONTRIBUTING FACTOR COULD BE A STUCK BLACK FOOT PEDAL, PREVENTING THE USER FROM RECOLLECTING, OR THE USER HAD THEIR FOOT ON THE BLACK FOOT PEDAL AS THEY ENTERED POST-OP BASELINE AND ATTEMPTED TO TAKE THE COLLECTION. THIS SCENARIO WAS DUPLICATED IN A CASE WHERE PRIOR TO ENTERING POST-OP BASELINE COLLECTION SCREEN, THE BLACK FOOT SWITCH WAS PRESSED DOWN AND REMAINED DOWN WHILE ATTEMPTING TO COLLECT THE BASELINE. THE COLLECTION COULD NOT REGISTER. THEREFORE, IT IS POSSIBLE THAT THE USER HAD THE BLACK FOOT PEDAL DEPRESSED WHEN ENTERING THE POST-OP BASELINE COLLECTION SCREEN, AND REMAINED DEPRESSED DURING COLLECTION, INSTEAD OF DEPRESSING THE FOOT PEDAL AFTER HAVING ENTERED THE POST-OP BASELINE COLLECTION SCREEN. THIS SITUATION IS CAPTURED IN THE RISK ASSESSMENT RELEASED AT THE TIME OF THE COMPLAINT. THE FAILURE MODE AND ASSOCIATED RISK HAVE BEEN ANTICIPATED WITHIN THE RISK FILE AND THAT THE DOCUMENTED RISK LEVEL IS STILL ADEQUATE. A REVIEW OF MANUFACTURING RECORDS INDICATE THE SOFTWARE MET ALL SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTS. A REVIEW OF PRIOR ESCALATION ACTIONS WAS PERFORMED AND FOUND NO ACTIONS THAT ARE APPLICABLE TO THE SCOPE OF THE REPORTED COMPLAINT. THIS ISSUE WILL BE CONTINUOUSLY MONITORED THROUGH COMPLAINT INVESTIGATION AND POST MARKET SURVEILLANCE. BASED ON THE INVESTIGATION, NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORI LAB/DEMO, WHEN THE PEDAL WAS NOT PRESSED DOWN, THE REAL INTELLIGENCE CORI RECORDED THE LEG GOING IN HYPER-EXTENSION DUE TO TRIALS NOT BEING IN PLACE. THE INFORMATION COULD NOT BE CORRECTED OR OVERWRITTEN EVEN WHEN RECOLLECTING THE POST-OP BASELINE AFTER CLEARING THE VALUES; THEREFORE, IT SHOWED AN INCORRECT RANGE OF MOTION INFORMATION IN THE PATIENT'S FILE (CASE-2021-00059799-1). MOREOVER, REAL INTELLIGENCE TABLET FLICKERED SEVERAL TIMES (CASE-2021-00059799-2). SINCE THE ISSUES OCCURRED IN A LAB DEMO, THERE WAS NO PATIENT INVOLVEMENT. THIS IS THE SECOND OF THREE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935784 REAL INTELLIGENCE CORI ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES ROB10024 00885556757420

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown