BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVILAS LASER SYSTEM

    MDR report key: 18008551 · Received October 25, 2023

    Report

    Report Number
    3008252121-2023-00001
    Event Type
    Injury
    Date Received
    October 25, 2023
    Date of Event
    September 19, 2023
    Report Date
    October 25, 2023
    Manufacturer
    OD-OS GMBH
    Product Code
    GEX
    PMA / PMN Number
    K162191
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2023 THE CUSTOMER REPORTED THAT LASER TREATMENT WAS NOT PERFORMED WHERE PLANNED. THE NAVILAS LASER SYSTEM WAS INSPECTED BY AN AUTHORIZED SERVICE TECHNICIAN ON (B)(6) 2023. DURING SERVICE BY THE DISTRIBUTOR, A PROBLEM WAS FOUND WITH THE X-SCANNER. THE REMOTE SERVICE ASSESSMENT PERFORMED BY THE MANUFACTURER SHOWS A CALIBRATION OFFSET OF THE AIMING BEAM THAT IS SIMILAR TO THE OFFSET OBSERVED ON THE RETINA IN THE FUNDUS IMAGES. THE NAVILAS SYSTEM WAS BLOCKED. THE OPTICAL HEAD WAS REPLACED ON (B)(6) 2023. FUNDUS PHOTOS WERE OBTAINED AND REVIEWED. IMAGE ANALYSIS CONFIRMED THE TREATMENT AREA WAS DELIVERED INSIDE THE EXCLUSION BOUNDARY (I.E., SHIFTED TO THE LEFT AND SLIGHTLY SUPERIOR). THE SERVICE INSTALLATION RECORDS WERE REVIEWED FOR THIS LASER SYSTEM AND THERE WERE NO PROBLEMS RELATED TO THE SCANNER CALIBRATION OR AIMING BEAM. THE SYSTEM LOG FILES WERE ANALYZED AND THE RECORDS CONFIRMED THAT THE USER IGNORED AND OVERRODE THE ERROR MESSAGES WARNING THAT THE AIMING BEAM WAS NOT VISIBLE. THE OPTICAL HEAD WAS RETURNED TO THE MANUFACTURER AND SUBJECTED TO PERFORMANCE TESTING AND ROOT CAUSE ANALYSIS. THE INVESTIGATION REVEALED UNIDENTIFIED SOURCES OF NOISE RECEIVED AT RANDOM INTERVALS, WHICH CAN RESULT IN LASER DRIFT/OFFSET AND INCORRECT LASER POSITIONING. THE ROOT CAUSE ANALYSIS IDENTIFIED A DEFECTIVE SCANNER DRIVER BOARD. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    A PATIENT WITH DIABETIC MACULAR EDEMA UNDERWENT A LASER PROCEDURE IN THE LEFT EYE ON (B)(6) 2023. ON (B)(6) 2023, THE PHYSICIAN REPORTED TO THE DISTRIBUTOR THAT THE TREATMENT BEAM WAS FAR AWAY FROM THE AIMING BEAM (OFFSET BY APPROXIMATELY 1 OR 2 MM). THE NAVILAS LASER SYSTEM GENERATED AN ERROR MESSAGE DURING A FOCAL PROCEDURE ALERTING THE USER THAT THE AIMING BEAM WAS NOT VISIBLE; HOWEVER, THE USER ELECTED TO PROCEED WITH THE LASER TREATMENT DESPITE THE WARNING MESSAGE. PATIENT FOLLOW-UP INFORMATION WAS REQUESTED FROM THE TREATING PHYSICIAN AND ON SEPTEMBER 28, 2023, IT WAS LEARNED THAT THE JUXTAFOVEOLAR LASER TREATMENT WAS INADVERTENTLY DELIVERED WITHIN THE PREDEFINED EXCLUSION ZONE AND NOT ON THE DESIRED/INTENDED TREATMENT ZONE. THE PATIENT IS UNDERGOING CONTINUED TREATMENT OF FOCAL EDEMA FOR INTRAVITREAL TRIAMCINOLONE (IVT) AND THE PROGRESSION OF MACULAR HEALTH WILL BE MONITORED. THERE HAS BEEN NO SIGNIFICANT DECREASE IN THE PATIENT'S BEST CORRECTED VISUAL ACUITY (BCVA) COMPARED TO PREOPERATIVE BCVA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1579239 NAVILAS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX OD-OS GMBH 577S

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Disability