BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVILAS LASER SYSTEM

    MDR report key: 20287880 · Received September 23, 2024

    Report

    Report Number
    3008252121-2024-00012
    Event Type
    Injury
    Date Received
    September 23, 2024
    Date of Event
    May 19, 2020
    Report Date
    September 23, 2024
    Manufacturer
    OD-OS GMBH
    Product Code
    GEX
    PMA / PMN Number
    K162191
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH THE SURGERY TOOK PLACE 4 YEARS AGO AND THE EVENT WAS ONLY RECENTLY REPORTED TO OD-OS, THE DEVICE HISTORY LOG FILES WERE AVAILABLE FOR THIS CASE. REVIEW AND EVALUATION OF THE LOG FILES DID NOT IDENTIFY A DEVICE MALFUNCTION; THERE WERE NO ERROR MESSAGES AND THE DEVICE FUNCTIONED AS INTENDED. THE LOG FILES REVEAL THE PHYSICIAN ACTIVATED THE LASER FOUR TIMES WITH INCREASING LASER POWER BASED ON A TREATMENT PLAN, WHICH IS TYPICAL FOR TITRATION. NO FURTHER LASER ENERGY WAS RELEASED. REVIEW OF THE PATIENT'S FUNDUS PHOTOS SHOWS 4 TITRATION POINTS WERE PLACED ABOVE THE VASCULAR RING. THE TITRATION VALUES RANGED FROM 900 MW, 950 MW, 1000 MW, TO 1050 MW. BLEEDING OCCURRED DURING THE FIRST TITRATION SHOT; NO BLEEDING OCCURRED WITH SUBSEQUENT TITRATION SHOTS. THE PLANNED SPOTS WITHIN THE MACULA WERE NOT TREATED. CENTRAL SEROUS CHOROIDOPATHY INCREASES THE RISK FOR RETINAL BLEEDING DUE TO THE INHERENT NATURE OF THE DISEASE. THE DEVICE INSTRUCTIONS FOR USE IDENTIFIES SUBRETINAL FIBROSIS AS POTENTIAL SIDE EFFECT OR COMPLICATION. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    A PATIENT WITH PREEXISTING CENTRAL SEROUS CHOROIDOPATHY UNDERWENT TREATMENT WITH THE NAVILAS® LASER SYSTEM 577S IN THE LEFT EYE ON (B)(6) 2020. THE TREATMENT WAS PLANNED AS THERAPY FOR THE PREEXISTING CONDITION. DURING LASER TREATMENT THERE WAS SIGNIFICANT SUBFOVEAL BLEEDING WITHIN THE MACULA THAT RESULTED IN SUBRETINAL FIBROSIS WITHIN THE MACULA. ADDITIONAL INFORMATION WAS REQUESTED AND THE TREATING PHYSICIAN CLARIFIED THAT SUBRETINAL BLEEDING OCCURRED IN THE MACULA DUE TO BLOOD RUNNING DOWN FROM THE TITRATION SPOT. ALTHOUGH THE EVENT DID NOT REQUIRE MEDICAL OR SURGICAL INTERVENTION AND THERE WAS NO PERMANENT DECREASE IN VISUAL ACUITY COMPARED TO BASELINE, THE PATIENT HAS PERSISTENT METAMORPHOPSIA AND SCOTOMAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175480 NAVILAS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX OD-OS GMBH 577S

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Disability