BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAL INTELLIGENCE CORI

    MDR report key: 10779183 · Received November 3, 2020

    Report

    Report Number
    3010266064-2020-01950
    Event Type
    Malfunction
    Date Received
    November 3, 2020
    Date of Event
    October 8, 2020
    Report Date
    January 12, 2022
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556757420
    PMA / PMN Number
    K191223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE RI CORI (US), ROB10024, (B)(6) INTENDED FOR USE IN TREATMENT WAS NOT RETURNED FOR EVALUATION; THUS, A VISUAL AND FUNCTIONAL EVALUATION COULD NOT BE PERFORMED, AND A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE COULD NOT BE DETERMINED. CORI-V1.4.0.7 HAS BEEN VALIDATED ON PP-153 REV C. A REVIEW OF MANUFACTURING RECORDS INDICATE THE SOFTWARE MET ALL SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOR SIMILAR REPORTED/CONFIRMED COMPLAINTS CONCLUDED THIS WAS AN ISOLATED EVENT. A CAPA, HHE/PRA, FIELD ACTION REVIEW WAS NOT COMPLETED. THE PRODUCT WAS NOT RETURNED AND NO EVIDENCE WAS MADE AVAILABLE TO LINK THE COMPLAINT TO A CAPA, HHE/PRA, FIELD ACTION. ALTHOUGH THE REPORTED PROBLEM WAS NOT CONFIRMED, A FACTOR THAT MAY HAVE CONTRIBUTED TO THE REPORTED SYMPTOM MAY BE ASSOCIATED WITH A SOFTWARE ISSUE. THIS FAILURE IS AN IDENTIFIED FAILURE MODE WITHIN THE RISK ASSESSMENT. ALTHOUGH NO FURTHER CONTAINMENT OR CORRECTIVE ACTION IS RECOMMENDED OR REQUIRED AT THIS TIME, ALL COMPLAINTS ARE MONITORED AND TRENDED THROUGH POST MARKET SURVEILLANCE ACTIVITIES. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED OR PROVIDED AT A FUTURE DATE, THIS EVALUATION WILL BE REOPENED FOR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORI LAB/DEMO, AFTER INSTRUCTING ASSOCIATES HOW TO TURN ON AND TURN OFF THE SYSTEM, THEY ALLOWED HIM TO POWER IT ON THEMSELVES. LATER, HE WAS INSTRUCTED TO TURN THE SYSTEM OFF AND LET THE OTHER ASSOCIATE HAVE A TURN. THE ORANGE CIRCLE AROUND THE POWER ICON ON THE CONSOLE¿S SCREEN WOULDN¿T DISAPPEAR AND, AFTER WAITING A LITTLE LONGER, IT NEVER WENT AWAY. THEY HIT START ON THE TABLET, ENTERED A PREVIOUSLY CREATED CASE, BUT THE CONSOLE SCREEN NEVER DISPLAYED THE THREE SLIDERS. THEY EXITED BACK TO THE START MENU ON THE TABLET AND FORCE QUIT THE SYSTEM WITH THE POWER SWITCH ON THE BACK OF THE CONSOLE. UPON RESTART THE SYSTEM POWERED UP AS EXPECTED. NO PATIENT WAS INVOLVED. NO OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247269 REAL INTELLIGENCE CORI ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES ROB10024 00885556757420

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown