BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAMERA, POLARIS VEGA

    MDR report key: 10911268 · Received November 26, 2020

    Report

    Report Number
    3010266064-2020-02041
    Event Type
    Malfunction
    Date Received
    November 26, 2020
    Date of Event
    November 9, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE POLARIS VEGA CAMERA, PRODUCT 200597, SN (B)(6) USED FOR TREATMENT WAS NOT MADE AVAILABLE TO THE DESIGNATED COMPLAINT UNIT FOR EVALUATION THUS, VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. 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 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 COMPONENT FAILURE; THE ILLUMINATOR LEDS ON THE CAMERA CAN GO BAD OVER TIME WITH USE AND CAUSE FLOATING "DEAD ZONES" IN THE CAMERA VIEW. THIS PROBLEM IS PHYSICAL IN NATURE IN THE CAMERA ONLY AND IT NEEDS TO BE SERVICED. 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 NAVIO TKA PROCEDURE, THE MESSAGE "INFRARED BULB OF THE CAMERA IS NOT WORKING CORRECTLY, CAMERA VIEW COULD BE AFFECTED." POPPED UP. THEY HIDE THE MESSAGE AND WERE ABLE TO FINISH THE SURGERY WITHOUT DELAYS. NO OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1374931 CAMERA, POLARIS VEGA ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1