BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIO SURGICAL SYSTEM INDIA

    MDR report key: 12321332 · Received August 13, 2021

    Report

    Report Number
    3010266064-2021-00605
    Event Type
    Malfunction
    Date Received
    August 13, 2021
    Date of Event
    August 2, 2021
    Report Date
    February 10, 2022
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556693506
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE NAVIO SURGICAL SYSTEM INDIA, PART NUMBER ROB00036, SERIAL (B)(6) AND INTENDED TO BE USED FOR TREATMENT, WAS NOT RETURNED FOR EVALUATION. A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE COULD NOT BE ESTABLISHED. A VISUAL/FUNCTIONAL INSPECTION CANNOT BE COMPLETED AS NO DEVICE WAS RETURNED FOR EVALUATION. A REVIEW OF MANUFACTURING RECORDS INDICATE THE DEVICE MET ALL SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOR SIMILAR REPORTED/CONFIRMED COMPLAINTS HAS IDENTIFIED PRIOR EVENTS. WHILE THE REPORTED PROBLEM WAS NOT CONFIRMED DURING EVALUATION, THE MOST PROBABLE CONTRIBUTING FACTOR(S) TO THE REPORTED PROBLEM IS COMPONENT FAILURE IN CPU. 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, H6: THE NAVIO CPU, PN 200509, SN (B)(6), INTENDED FOR USE IN TREATMENT, WAS RETURN FOR EVALUATION. THE REPORTED EVENT WAS CONFIRMED FUNCTIONALLY. THE CPU WAS CONNECTED TO THE NAVIO SYSTEM AND IT FAILED TO OPERATED. IT WAS DISSEMBLE TO SEE IF THERE WAS ANY BOARD OR CARD LOOSE, AND NOTHING WAS OBSERVE. THE VIDEO CARD WAS RESEATED, BUT THE ISSUE PERSISTED. 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. THE MOST LIKELY CAUSE OF THIS EVENT IS A FAILURE IN THE VIDEO CARD AND/OR MOTHERBOARD. A HISTORICAL CAPA, NC, HHE/PRA, FIELD ACTION REVIEW WAS COMPLETED. A REVIEW OF PRIOR ESCALATION ACTIONS FOUND NO ACTIONS APPLICABLE TO THE SCOPE OF THIS CASE. THE FAILURE MODE AND ASSOCIATED RISK HAVE BEEN ANTICIPATED WITHIN THE RISK FILE AND THAT 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 THROUGH COMPLAINT INVESTIGATION AND POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING NAVIO PREVENTATIVE MAINTENANCE, THE CPU DID NOT BOOT UP. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215953 NAVIO SURGICAL SYSTEM INDIA ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES 00885556693506

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNKN NAVIO ROBOTICS INSTR/SERIAL: (B)(6)