BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVILAS LASER SYSTEM

    MDR report key: 18728183 · Received February 17, 2024

    Report

    Report Number
    3008252121-2024-00011
    Event Type
    Malfunction
    Date Received
    February 17, 2024
    Date of Event
    January 19, 2024
    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 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 (B)(6) 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. MANUFACTURER REFERENCE #: (B)(4).

    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).

    Description of Event or Problem · 0

    A PATIENT UNDERWENT TREATMENT WITH THE NAVILAS® LASER SYSTEM 577S SOMETIME BETWEEN (B)(6) 2023 AND (B)(6) 2024. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425383 NAVILAS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX OD-OS GMBH 577S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown