BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVILAS LASER SYSTEM 577S

    MDR report key: 24754074 · Received April 1, 2026

    Report

    Report Number
    3008252121-2026-00001
    Event Type
    Injury
    Date Received
    April 1, 2026
    Date of Event
    March 3, 2026
    Report Date
    April 1, 2026
    Manufacturer
    OD-OS GMBH
    Product Code
    GEX
    UDI-DI
    04260284390013
    PMA / PMN Number
    K162191
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO MALFUNCTION IS EVIDENT AT THIS STAGE. THE POSSIBLE CAUSES OF THIS EVENT WERE: USER ERROR (IGNORING AIMING BEAM WARNINGS AND IFU), LABELING, OR USABILITY ISSUES. NONETHELESS, EVALUATION OF LABELLING AND INFORMATION PROVIDED BY THE MANUFACTURER (BOTH ON IFU AND GRAPHIC USER INTERFACE) WAS ADEQUATE. THE USER ELECTED TO PROCEED WITH THE LASER TREATMENT DESPITE THE WARNING MESSAGE. THUS, NO FIELD SAFETY CORRECTIVE ACTION IS NECESSARY. 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. HOWEVER, AS THE INVESTIGATION IS STILL ONGOING. THE OPTICAL HEAD WILL BE SENT TO THE OD-OS FACILITY FOR TESTING TO DETERMINE WHETHER ANY MALFUNCTION MAY HAVE OCCURRED. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2026, THE CUSTOMER REPORTED HEARING A STRANGE "STATIC NOISE" COMING FROM THE LASER OPTICAL HEAD OF A NAVILAS 577S LASER SYSTEM DEVICE (SN (B)(6)) LASTING APPROXIMATELY 5 MINUTES BEFORE DISAPPEARING. SUBSEQUENTLY, THE CUSTOMER PERFORMED A TREATMENT SESSION, AND UPON REVIEW OF THE TREATMENT DOCUMENTATION, THE PHYSICIAN OBSERVED THE LASER FIRING WITHIN THE SET EXCLUSION BOUNDARY RATHER THAN THE INTENDED TREATMENT ZONE. THE SYSTEM'S LOG FILES FROM THE DATE OF THE INCIDENT SHOWED MULTIPLE WARNINGS RELATED TO THE AIMING BEAM POSITION NOT BEING VERIFIED, INCLUDING: · "AIMING BEAM POSITION COULD NOT BE VERIFIED. IMPROVE AIMING BEAM VISIBILITY." "SYSTEM IS UNABLE TO CONFIRM AIMING BEAM POSITION." · "REJECTED SPOT APPLICATION DUE TO MISSING AIMING BEAM POSITION." THE USER ELECTED TO PROCEED WITH THE LASER TREATMENT DESPITE THE WARNING MESSAGES. THE TREATMENT IMAGES LATER SHOWED SPOT OFFSET IN TWO TREATMENT PATTERNS, INCLUDING SOME SPOTS WITHIN THE EXCLUSION AREA. NO BURNS WERE VISIBLE IN THE CENTRAL MACULA, AND THE FOVEA WAS NOT AFFECTED. THE PHYSICIAN REPORTED THAT NO SIGNIFICANT VISION LOSS WAS OBSERVED NOR IS EXPECTED, AND THE PATIENT'S PROGNOSIS IS GOOD. SERVICE INSPECTIONS WERE PERFORMED ON (B)(6) 2026, AND IT WAS CONFIRMED THAT: CALIBRATION OF THE OPTICAL HEAD WAS WITHIN SPECIFICATION. · AIMING BEAM ALIGNMENT WAS CORRECT. NO ABNORMAL NOISE COULD BE REPRODUCED. THE SYSTEM FUNCTIONED NORMALLY DURING SIMULATED TREATMENTS. AT THIS STAGE, NO DEVICE MALFUNCTION HAS BEEN IDENTIFIED. DEVICE WARNINGS AND SAFETY MESSAGES OPERATED AS DESIGNED. THE INVESTIGATION IS ONGOING, AND THE OPTICAL HEAD WILL UNDERGO FURTHER TESTING AT THE MANUFACTURER'S FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201650 NAVILAS LASER SYSTEM 577S POWERED LASER SURGICAL INSTRUMENT GEX OD-OS GMBH NAVILAS® LASER SYSTEM 577S 04260284390013

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Disability