BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAMERA, POLARIS VEGA

    MDR report key: 19671560 · Received July 3, 2024

    Report

    Report Number
    3010266064-2024-00146
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    June 7, 2024
    Report Date
    July 22, 2024
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    PMA / PMN Number
    K152574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    THE CAMERA, POLARIS VEGA, PART NUMBER 200597, SERIAL NUMBER (B)(6), INTENDED FOR TREATMENT WAS NOT RETURNED FOR EVALUATION, THEREFORE A DEVICE ANALYSIS WAS UNABLE TO BE PERFORMED. A COMPLAINT HISTORY REVIEW FOR SIMILAR REPORTED/CONFIRMED COMPLAINTS CONCLUDED THIS WAS AN ISOLATED EVENT. A REVIEW OF MANUFACTURING RECORDS INDICATE THE DEVICE MET ALL SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. THE FAILURE MODE AND ASSOCIATED RISK HAVE BEEN ANTICIPATED WITHIN THE RISK FILE AND THE DOCUMENTED RISK LEVEL IS STILL ADEQUATE. A HISTORICAL ESCALATION EVENT REVIEW WAS NOT COMPLETED. THE PRODUCT WAS NOT RETURNED AND NO EVIDENCE WAS MADE AVAILABLE TO LINK THE COMPLAINT TO AN ESCALATION EVENT. WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. ALTHOUGH THE REPORTED PROBLEM WAS NOT CONFIRMED THROUGH A VISUAL OR FUNCTIONAL EVALUATION, FACTORS CONTRIBUTING TO THE REPORTED SYMPTOM MAY HAVE BEEN ASSOCIATED WITH CAMERA SHOCK SENSOR BATTERY NEEDS TO BE CHARGED. BASED ON THE INVESTIGATION, NO CONTAINMENT OR CORRECTIVE ACTION IS RECOMMENDED OR REQUIRED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. THE FAILURE MODE WILL CONTINUE TO BE CLOSELY MONITORED THROUGH COMPLAINT INVESTIGATION AND TRENDED THROUGH POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A NAVIO ASSISTED TKA SURGERY, AN ERROR HAD OCCURRED ON A CAMERA, POLARIS VEGA IMMEDIATELY AFTER STARTING THE PROCEDURE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, CHANGING THE SURGICAL TECHNIQUE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE. AFTERWARD, THE SERVICE TEAM HAS CONFIRMED THAT THE CAUSE OF THIS FAILURE WAS RUN OUT OF THE BATTERY FOR SENSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133726 CAMERA, POLARIS VEGA ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PN: ROB00043 / SN: (B)(6)