BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAMERA, POLARIS VEGA

    MDR report key: 10972136 · Received December 8, 2020

    Report

    Report Number
    3010266064-2020-02100
    Event Type
    Malfunction
    Date Received
    December 8, 2020
    Date of Event
    November 23, 2020
    Report Date
    July 20, 2021
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    PMA / PMN Number
    K191223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE POLARIS VEGA CAMERA, PRODUCT 200597, INTENDED FOR USE IN TREATMENT WAS NOT MADE AVAILABLE TO THE DESIGNATED COMPLAINT UNIT FOR EVALUATION THUS, VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. WHILE ALL PRODUCTS MEET REQUIRED MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE, A SERIAL NUMBER IS REQUIRED TO COMPLETE A REVIEW OF NC AND SERVICE RECORDS. A COMPLAINT HISTORY REVIEW FOR SIMILAR REPORTED/CONFIRMED COMPLAINTS HAS IDENTIFIED PRIOR EVENTS. A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE COULD NOT BE ESTABLISHED AS THE PRODUCT WAS NOT RETURNED. ALTHOUGH THE REPORTED PROBLEM WAS NOT CONFIRMED, A CONTRIBUTING FACTOR MAY BE CABLE FAILURE RESULTING IN COMMUNICATION FAILURE. 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 AT A FUTURE DATE, THIS EVALUATION WILL BE REOPENED FOR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A NAVO DRY SAWBONE DEMO, THE VEGA CAMERA FAILED TO CONNECT, BUT HAD POWER, THEY BYPASSED DIRECTLY POE TO CAMERA AND WORKED FINE. NO PATIENT WAS INVOLVED. NO OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1437268 CAMERA, POLARIS VEGA ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1