BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAL INTELLIGENCE TRACKING CAMERA

    MDR report key: 12727707 · Received November 1, 2021

    Report

    Report Number
    3010266064-2021-00737
    Event Type
    Malfunction
    Date Received
    November 1, 2021
    Date of Event
    October 8, 2021
    Report Date
    May 2, 2022
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556757437
    PMA / PMN Number
    K193120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: THE REAL INTELLIGENCE TRACKING CAMERA (FRANCE), ROB10025, S/N (B)(6) INTENDED FOR USE IN TREATMENT WAS RETURNED FOR EVALUATION. A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE WAS ESTABLISHED. NOTHING WAS IDENTIFIED VISUALLY THAT CONTRIBUTED TO THE REPORTED PROBLEM. A FUNCTIONAL EVALUATION WAS COMPLETED. THE CAMERA WAS CONNECTED TO A CORI SYSTEM. THE REPORTED PROBLEM WAS CONFIRMED. THE CAMERA IS NOT RECOGNIZED BY THE CORI SYSTEM AT THE CONNECTION SCREEN. AN ATTEMPT WAS MADE TO UPDATE THE CAMERA FIRMWARE. THE MESSAGE "CAMERA FAILED TO INITIALIZE" PRESENTED. AN ATTEMPT WAS MADE TO CONNECT VIA SYSTEM AND KEYBOARD AND THE MESSAGE "CANNOT FIND ANY DEVICES" PRESENTED. THE MOST LIKELY CAUSE OF THIS EVENT IS AN INTERNAL FAILURE OF THE CAMERA. THE CAMERA IS AN OEM DEVICE AND CANNOT BE FURTHER DISASSEMBLED TO ARRIVE AT A ROOT CAUSE. A REVIEW OF MANUFACTURING AND SERVICE RECORDS INDICATE THE DEVICE MET ALL SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOR SIMILAR REPORTED/CONFIRMED COMPLAINTS HAS IDENTIFIED PRIOR EVENTS. A HISTORICAL ESCALATION EVENT REVIEW WAS COMPLETED. A REVIEW OF PRIOR ESCALATION ACTIONS FOUND NO ACTIONS APPLICABLE TO THE SCOPE OF THE REPORTED COMPLAINT. THE FAILURE MODE AND ASSOCIATED RISK HAVE BEEN ANTICIPATED WITHIN THE RISK FILE AND THE DOCUMENTED RISK LEVEL IS STILL ADEQUATE. 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.

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT REFERENCE CASE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORI CADAVER LAB DEMONSTRATION. THE REAL INTELLIGENCE TRACKING CAMERA WAS NOT RECOGNIZED. THE LED LIGHTS WERE DISPLAYED NORMALLY BUT THE LOGO ON THE SCREEN SHOWED THE CAMERA AS UNRECOGNIZED. THEY TRIED TO CHANGE THE ETHERNET CABLE, HAD THE SAME ISSUE. THEY SWITCHED TO ANOTHER CAMERA AND THE CORI WORKED. AS THIS HAPPENED IN A DEMONSTRATION, THERE WAS NOT PATIENT INVOLVEMENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1629603 REAL INTELLIGENCE TRACKING CAMERA ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES ROB10025 00885556757437

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ROB20000-CORI ROBOTICS USA| ROB20000-CORI ROBOTICS USA