BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVILAS LASER SYSTEM

    MDR report key: 18728159 · Received February 17, 2024

    Report

    Report Number
    3008252121-2024-00008
    Event Type
    Malfunction
    Date Received
    February 17, 2024
    Date of Event
    December 18, 2023
    Report Date
    April 24, 2024
    Manufacturer
    OD-OS GMBH
    Product Code
    GEX
    PMA / PMN Number
    K162191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PERFORMED A THOROUGH DEVICE EVALUATION THAT CONSISTED OF REMOTE DIAGNOSTICS, ON-SITE SERVICING, AND IN-HOUSE TESTING OF THE REPLACED OPTICAL HEAD COMPONENTS. THE INVESTIGATION CONFIRMED THE DEVICE MALFUNCTION AND IDENTIFIED A DEFECTIVE SCANNER DRIVER BOARD AND GALVO MOTOR WHICH CAUSED UNPREDICTABLE AIMING BEAM MOVEMENTS. THE SCANNER DRIVER BOARD AND GALVO MOTOR WERE REPLACED AND THE DEVICE WAS RETURNED TO SPECIFICATION. A CAPA INVESTIGATION WAS INITIATED FOR THOROUGHNESS OF THE ROOT CAUSE ANALYSIS AND THERE IS NO INDICATION OF A SYSTEMIC PROBLEM. THE CAPA INVESTIGATION RULED OUT A MECHANICAL PROBLEM AND NARROWED THE SOURCE TO AN ELECTRICAL PROBLEM. THERE HAVE BEEN NO NEW REPORTS OF SIMILAR ISSUES. MANUFACTURER REFERENCE #:(B)(4).

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER INSTRUCTED THE CLINIC NOT TO USE THE LASER SYSTEM UNTIL THE DEVICE CAN BE EVALUATED AND SERVICED. THE NAVILAS LASER SYSTEM WAS INSPECTED BY AN AUTHORIZED SERVICE TECHNICIAN ON FEBRUARY 2, 2024. DURING SERVICE, A PROBLEM WAS FOUND WITH THE Y-SCANNER AND THE OPTICAL HEAD WAS REPLACED. THE OPTICAL HEAD IS BEING SENT BACK TO THE MANUFACTURER FOR ANALYSIS AND THE FINDINGS AND CONCLUSIONS WILL BE SUBMITTED IN A FOLLOW-UP REPORT. DURING THE SERVICE VISIT THE LOG FILES WERE REVIEWED WHICH REVEALED THAT THE SYSTEM PRODUCED THE CORRECT ERROR MESSAGE ABOUT THE AIMING BEAM NOT BEING VISIBLE (I.E., "WARNING AIMING BEAM POSITION COULD NOT BE VERIFIED.TXT"). HOWEVER, THE USER IGNORED THE ERROR MESSAGE AND OVERRODE THE WARNING AND PROCEEDED WITH THE TREATMENT. FUNDUS PHOTOS WERE OBTAINED AND REVIEWED. IMAGE ANALYSIS CONFIRMED THE TREATMENT AREA WAS DELIVERED IN THE INCLUSION AREA (I.E., EXTRA-MACULAR AREA ). ACCORDING TO THE SYSTEM RISK ANALYSIS, DAMAGE TO THIS AREA HAS NO ADVERSE FUNCTIONAL IMPACT ON VISION AND IS THEREFORE CONSIDERED TRIVIAL PERMANENT TISSUE DAMAGE. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    A PATIENT WITH A PREEXISTING VITREOUS HEMORRHAGE IN THE RIGHT EYE UNDERWENT TREATMENT WITH THE NAVILAS® LASER SYSTEM 577S ON (B)(6) 2023. THE CLINIC REPORTED EXPERIENCING A DEVICE MALFUNCTION DURING TREATMENT WHEREBY THE GRID THAT SHOWS WHERE THE LASER TREATMENT SHOULD BE DELIVERED WAS NOT ALIGNED WITH THE ACTUAL TREATMENT AREA. THE MALFUNCTION DID NOT RESULT IN PATIENT INJURY AND THERE WAS NO UNINTENTIONAL TISSUE DAMAGE AS A CONSEQUENCE OF THE EVENT. THERE HAS BEEN NO DECREASE IN THE PATIENT'S BEST CORRECTED VISUAL ACUITY (BCVA) COMPARED TO PREOPERATIVE BCVA AND NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. POSTOPERATIVELY THE PATIENT WAS REPORTED AS BEING IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451152 NAVILAS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX OD-OS GMBH 577S

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male