BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVILAS LASER SYSTEM

    MDR report key: 18481989 · Received January 10, 2024

    Report

    Report Number
    3008252121-2024-00001
    Event Type
    Injury
    Date Received
    January 10, 2024
    Date of Event
    June 1, 2023
    Report Date
    January 10, 2024
    Manufacturer
    OD-OS GMBH
    Product Code
    GEX
    PMA / PMN Number
    K162191
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUBLICATION (REFERENCE BELOW) DESCRIBES FULL DETAILS OF THE STUDY DESIGN AND REPORTS AN OVERALL INCIDENCE OF (B)(4) WITH SIMILAR POSTOPERATIVE FINDINGS AND ETIOLOGY. THE OTHER (B)(4) ARE DESCRIBED IN SEPARATE 3500A REPORTS. THERE WAS NO REPORT OF A DEVICE MALFUNCTION. THE MANUFACTURER PERFORMED A ROOT CAUSE INVESTIGATION AND CONCLUDED THAT THE EVENT WAS CAUSED BY USE ERROR WHERE THE TREATMENT PARAMETER VALUES (ENERGY FLUENCE) INTENTIONALLY PROGRAMMED BY THE INVESTIGATOR WERE SIGNIFICANTLY HIGHER THAN PRACTICE GUIDELINES AND HAVE A HIGH PROBABILITY OF INDUCING PERMANENT RETINAL DAMAGE. THE OPERATOR'S MANUAL INCLUDES THE FOLLOWING WARNING STATEMENTS: WARNING: INCORRECT TREATMENT SETTINGS CAN CAUSE SERIOUS TISSUE DAMAGE. THEREFORE, IT IS RECOMMENDED TO USE THE LOWEST ACCEPTABLE TREATMENT SETTINGS UNTIL USERS ARE MORE FAMILIAR WITH THE NAVILAS® LASER SYSTEM (B)(4). USE EXTREME CAUTION UNTIL THE BIOLOGICAL INTERACTION BETWEEN THE LASER ENERGY AND TISSUE IS THOROUGHLY UNDERSTOOD. WARNING: THE TREATMENT PARAMETERS, THE LASER POSITION AND ALL LASER SETTINGS ARE THE SOLE RESPONSIBILITY OF THE OPERATOR. THE SOFTWARE DOES NOT ANALYZE TREATMENT PARAMETERS TO IDENTIFY INAPPROPRIATE SETTINGS OR CHECKS FOR THE SAFETY OF LASER SETTING COMBINATIONS. THE OPERATOR MUST THOROUGHLY UNDERSTAND LASER TISSUE INTERACTIONS AND POWER SETTINGS FOR SPECIFIC LASER WAVELENGTHS AND SYSTEMS. USE EXTREME CAUTION UNTIL THE BIOLOGICAL INTERACTION BETWEEN THE LASER ENERGY AND TISSUE IS THOROUGHLY UNDERSTOOD. INADVERTENT FOVEAL BURNS, PARACENTRAL SCOTOMATA, AND DECREASED VISION ARE LISTED IN THE DEVICE LABELING AS POSSIBLE COMPLICATIONS. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A POTENTIAL QUALITY ISSUE WITH RESPECT TO MANUFACTURING, DESIGN, OR LABELING. ENRIQUEZ-FUENTES JE, ALARCON-GARCIA AD, ORIBIO-QUINTO C, FERNANDEZ-VIGO JI. HYPERPLASIA OF THE RETINAL PIGMENT EPITHELIUM SECONDARY TO SUBTHRESHOLD LASER TREATMENT IN CHRONIC CENTRAL SEROUS CHORIORETINOPATHY. PHOTODIAGNOSIS PHOTODYN THER. 2023 DEC:44:103896. DOI:10.1016/J.PDPDT.2023.103896. MANUFACTURER REFERENCE #: (B)(4) (CASE 1).

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED IN THE LITERATURE. A SUBJECT WITH PREEXISTING ATYPICAL CHRONIC CENTRAL SEROUS CHORIORETINOPATHY (CSCR) WITH PERSISTENT SUBRETINAL FLUID (SRF) WAS ENROLLED IN A PROSPECTIVE OBSERVATIONAL STUDY. THE PATIENT UNDERWENT A SINGLE SUBTHRESHOLD LASER (STL) TREATMENT SESSION WITH THE NAVILAS LASER SYSTEM (B)(4) PRIME CONFIGURATION IN THE LEFT EYE. THE TREATMENT PARAMETERS WERE AS FOLLOWS: (B)(4) DELIVERED, (B)(4) TOTAL APPLIED ENERGY, (B)(4) AVERAGE FLUENCE, AND (B)(4) DUTY CYCLE; TREATMENT WAS NOT TITRATED. THE TREATMENT WAS EFFECTIVE IN RESOLVING THE SRF. TWO MONTHS POSTOPERATIVELY, OCT IMAGING SHOWED WHAT THE AUTHORS DESCRIBE AS "HYPERPLASIA" OF THE RETINAL PIGMENT EPITHELIUM (RPE) IN THE LEFT EYE WITH A 35-LETTER DECREASE IN BEST CORRECTED VISUAL ACUITY (BCVA). THE HYPERPLASIA IS CONSISTENT WITH A LASER BURN. THE AUTHORS CONCLUDE THAT THE EVENT WAS ATTRIBUTED TO EXCESSIVE ENERGY THAT WAS PROGRAMMED AND EMPLOYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1142961 NAVILAS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX OD-OS GMBH 577S

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Disability