BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAL INTELLIGENCE CORI

    MDR report key: 14639593 · Received June 8, 2022

    Report

    Report Number
    3010266064-2022-00466
    Event Type
    Malfunction
    Date Received
    June 8, 2022
    Date of Event
    May 23, 2022
    Report Date
    September 6, 2022
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556757420
    PMA / PMN Number
    K193120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    H3, H6: THE REAL INTELLIGENCE CORI, PART NUMBER ROB10024, USED FOR TREATMENT WAS NOT RETURNED FOR EVALUATION. A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE COULD NOT BE ESTABLISHED. 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. ALTHOUGH THE REPORTED PROBLEM WAS NOT CONFIRMED THROUGH A VISUAL OR FUNCTIONAL EVALUATION, FACTORS CONTRIBUTING TO THE REPORTED SYMPTOM MAY HAVE BEEN ASSOCIATED WITH CONSOLE 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 · 0

    IT WAS REPORTED THAT, DURING A CORI LAB/DEMO, THEY STARTED A TKA CASE, PLUGGED IN THE REAL INTELLIGENCE ROBOTIC DRILL, UNLOCKED THE DRILL, RECEIVED CRITICAL DRILL ERROR AND GOT BOOTED FROM CASE. SO, THEY WENT TO DRILL DIAGNOSTIC, TRIED TO UNLOCK THE REAL INTELLIGENCE ROBOTIC DRILL AND GOT SOME SOUNDS. IN ADDITION, THEY WERE NOT ABLE TO INSERT THE BURR NOR PUSHED THE CARRIAGE BACK WITH BURR, TRIED AGAIN AND WAS NO MOVEMENT INSIDE THE DRILL. THE RI ROBOTIC DRILL ATTACHMENT AND REAL INTELLIGENCE ROBOTIC DRILL TRACKER ARE STUCK ON THE REAL INTELLIGENCE ROBOTIC DRILL. THEY TRIED TO GET THE ATTACHMENT OFF WITH VICE GRIPS WITH NO LUCK. THEN, TRIED REBOOTING, AND HAD NO LUCK. THE LAB/DEMO WAS PERFORMED, USING A S+N BACK-UP DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679846 REAL INTELLIGENCE CORI ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES ROB10024 00885556757420

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown REAL INTELLIGENCE ROBOTIC DRILL TRACKER