BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORI ROBOTICS USA

    MDR report key: 11988910 · Received June 13, 2021

    Report

    Report Number
    3010266064-2021-00442
    Event Type
    Malfunction
    Date Received
    June 13, 2021
    Date of Event
    December 12, 2020
    Report Date
    March 10, 2022
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556757420
    PMA / PMN Number
    K201022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE RI CORI (US), ROB10024, SN(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. A REVIEW OF MANUFACTURING RECORDS INDICATE THE SOFTWARE MET ALL SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOR SIMILAR REPORTED/CONFIRMED COMPLAINTS HAS IDENTIFIED PRIOR EVENTS. 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.

    Additional Manufacturer Narrative · 0

    H3, H8: THE RI CORI (US), (B)(6), SN(B)(6) INTENDED FOR USE IN TREATMENT WAS RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR EVALUATION. A VISUAL INSPECTION AND FUNCTIONAL EVALUATION WERE DONE ON THE CONSOLE. THERE WERE NO VISUAL OR FUNCTIONAL NON-CONFORMANCES RELATED TO THE REPORTED EVENT IDENTIFIED. THE SOFTWARE FILES WERE DOWNLOADED FROM THE DEVICE AND PROVIDED FOR INVESTIGATION. THE REPORTED SYSTEM CONSOLE IS BAD ERROR MESSAGE AND THE INTERNAL ERROR MESSAGE WERE CONFIRMED. THE SYSTEM CONSOLE IS BAD ERROR MESSAGE WAS THROWN APPROPRIATELY DUE TO THE OVERHEATING OF THE EXPOSURE MOTOR. THE INTERNAL ERROR MESSAGE PRESENTED IS A KNOWN SOFTWARE ISSUE, NO FURTHER CONTAINMENT OR CORRECTIVE ACTION IS REQUIRED AT THIS TIME. 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 WHEN THEY WENT TO BURR DURING A CORI LAB/DEMO WITH A CONSOLE UNIT FROM FIELD, THE SYSTEM THREW A "SYSTEM CONSOLE IS BAD" ERROR. THE ERROR WAS DISMISSED, EXITED, BUT THE LAUCHER GAVE AN "INTERNAL ERROR". NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885724 CORI ROBOTICS USA ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES ROB10024 00885556757420

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown