BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIO SURGICAL SYSTEM AU

    MDR report key: 10934720 · Received December 2, 2020

    Report

    Report Number
    3010266064-2020-02060
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Date of Event
    November 11, 2020
    Report Date
    March 14, 2022
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    PMA / PMN Number
    K191223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE NAVIO SURGICAL SYSTEM UPS (AUSTRALIA) P/N 200616 S/N (B)(6) INTENDED FOR USE IN TREATMENT WAS RETURNED FOR EVALUATION. A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE WAS NOT ESTABLISHED. NOTHING WAS IDENTIFIED VISUALLY THAT CONTRIBUTED TO THE REPORTED PROBLEM. A FUNCTIONAL EVALUATION WAS PERFORMED. THE UPS WAS CHARGED FOR 24 HOURS THEN INSERTED INTO A NAVIO SYSTEM. THE REPORTED PROBLEM WAS NOT CONFIRMED. THE UPS FUNCTIONED PROPERLY WITH NO ERRORS OR ISSUES IDENTIFIED. 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. ALTHOUGH THE REPORTED PROBLEM WAS NOT CONFIRMED, A FACTOR THAT MAY HAVE CONTRIBUTED TO THE REPORTED SYMPTOM MAY HAVE BEEN ASSOCIATED WITH INADEQUATE CHARGING TIME. 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 NAVIO SURGICAL SYSTEM USER'S MANUAL PROVIDES INSTRUCTIONS FOR PROPER SET UP OF THE DEVICE AND ACCESSORIES. THIS 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 · 0

    H3, H6: THE NAVIO SURGICAL SYSTEM UPS (AUSTRALIA) P/N 200616 S/N (B)(6) INTENDED FOR USE IN TREATMENT WAS RETURNED FOR EVALUATION. A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE WAS NOT ESTABLISHED. NOTHING WAS IDENTIFIED VISUALLY THAT CONTRIBUTED TO THE REPORTED PROBLEM. A FUNCTIONAL EVALUATION WAS PERFORMED. THE UPS WAS CHARGED FOR 24 HOURS THEN INSERTED INTO A NAVIO SYSTEM. THE REPORTED PROBLEM WAS NOT CONFIRMED. THE UPS FUNCTIONED PROPERLY WITH NO ERRORS OR ISSUES IDENTIFIED. 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. ALTHOUGH THE REPORTED PROBLEM WAS NOT CONFIRMED, A FACTOR THAT MAY HAVE CONTRIBUTED TO THE REPORTED SYMPTOM MAY HAVE BEEN ASSOCIATED WITH INADEQUATE CHARGING TIME. 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 NAVIO SURGICAL SYSTEM USER'S MANUAL PROVIDES INSTRUCTIONS FOR PROPER SET UP OF THE DEVICE AND ACCESSORIES. THIS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A NAVIO PREVENTIVE MAINTENANCE, THERE WAS AN UPS COMMUNICATION ERROR WITH A BRAND NEW SET OF BATTERIES. THE CHARGING CIRCUIT MAY BE FAULTY. THEY TRIED THE RECOMMENDED TROUBLESHOOTING TO NO AVAIL (WITH THE NAVIO COMPLETELY POWERED OFF, THEY UNPLUGGED THE POWER CORD AND TURN ON THE UNIT. ONCE THEY SAW THE NAVIO SPLASH SCREEN, THEY RECONNECTED THE POWER CORD. THE RED LIGHT SHOULD GO OFF AND THE NAVIO SHOULD BOOT NORMALLY. IF IT BOOTS UP NORMALLY POWER IT BACK DOWN AND LET IT CHARGE A FEW MINUTES AND POWER BACK UP. IF THE RED LIGHT COMES BACK THEN THERE IS LIKELY A BATTERY OR UPS PROBLEM). THEY REPLACED THE UPS AND THE SYSTEM RETURNED TO FULL FUNCTIONALITY. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400254 NAVIO SURGICAL SYSTEM AU ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ISOLATION TRANSFORMER/UPS, U.S.| ISOLATION TRANSFORMER/UPS, U.S.