BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAMERA, POLARIS SPECTRA

    MDR report key: 9999251 · Received April 25, 2020

    Report

    Report Number
    3010266064-2020-01382
    Event Type
    Injury
    Date Received
    April 25, 2020
    Date of Event
    November 11, 2019
    Report Date
    August 16, 2020
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    PMA / PMN Number
    K191223
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: H3, H6: THE DEVICE, INTENDED TO USE IN TREATMENT, WAS RETURNED FOR EVALUATION. A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE WAS ESTABLISHED AS THE REPORTED PROBLEM WAS CONFIRMED. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTS, THIS ISSUE WILL CONTINUE TO BE MONITORED. DHR REVIEW FOUND THAT NO CONDITIONS THAT COULD CONTRIBUTE TO THE REPORTED EVENT WERE FOUND. THE REPORTED PRODUCT MET MANUFACTURING SPECIFICATIONS PRIOR TO BEING RELEASED FOR DISTRIBUTION. THE SURGICAL USER'S MANUAL PROVIDES INSTRUCTIONS IN THE " TROUBLESHOOTING INFORMATION¿ SECTION: "CAMERA ERROR SYSTEM MESSAGE: CAMERA INFRARED LAMP IS NOT WORKING PROPERLY. THIS MAY RESULT IN A LIMITED FIELD OF VIEW.-YOU MAY CHOOSE TO QUIT THE INTRAOPERATIVE PROCEDURE OR CONTINUE. IF YOU CHOOSE TO CONTINUE, THE CAMERA WILL CONTINUE TO STILL FUNCTION, HOWEVER, THE CAMERA MAY HAVE LIMITED VISIBILITY." ACCORDINGLY, PRODUCT LABELING HAS BEEN RULED OUT AS A CAUSE OF THE COMPLAINT. THE PERFORMED CLINICAL / MEDICAL INVESTIGATION INDICATES: "THE PROCEDURE WAS COMPLETED WITH MANUAL INSTRUMENTATION. THE PATIENT OUTCOME WAS NOT PROVIDED. NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME; SHOULD CLINICALLY RELEVANT DOCUMENTATION BECOME AVAILABLE IN THE FUTURE, THE MEDICAL INVESTIGATION TASK MAY BE RE-EVALUATED." VISUAL INSPECTION FOUND THE EXTERIOR CONDITION SHOWS MINOR WEAR (SMUDGES). DURING FUNCTIONAL EVALUATION, THE REPORTED COMPLAINT WAS CONFIRMED. THE CAMERA ILLUMINATOR FAILURE ERROR OCCURED WHILE ATTEMPTING AN AAK ASSESSMENT. THE AMBER ERROR LED IS PRESENT. THE CAMERA EVENT LOG WAS EVALUATED AND IT SHOWED NUMEROUS ILLUMINATOR ERRORS BETWEEN (B)(6) 2019 - (B)(6) 2020. THE CAMERA WAS CONNECTED TO A SYSTEM AND CASE (CUT MODE) FOR 4 HOURS. THE INFRARED LAMP ERROR WAS PRESENT. THIS FAILURE IS AN IDENTIFIED FAILURE MODE WITHIN THE RISK ASSESSMENT. THE ROOT CAUSE WAS ESTABLISHED TO BE SUPPLIER / RAW MATERIAL FAULT. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LED ON THE CAMERA WAS ACTIVE AND THE FOLLOWING ERROR WAS DISPLAYED ON SCREEN: "CAMERA INFRARED LAMP IS NOT WORKING PROPERLY. THIS MAY RESULT IN A LIMITED FIELD OF VIEW". THIS WAS NOTICED BEFORE SURGERY; THEREFORE, THE NAVIO CASE WAS ABORTED AND THE PROCEDURE WAS PERFORMED WITH MANUAL INSTRUMENTS. THE PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462669 CAMERA, POLARIS SPECTRA ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1