BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVILAS LASER SYSTEM

    MDR report key: 7054941 · Received November 22, 2017

    Report

    Report Number
    3008252121-2017-00001
    Event Type
    Injury
    Date Received
    November 22, 2017
    Date of Event
    May 13, 2016
    Report Date
    November 22, 2017
    Manufacturer
    OD-OS GMBH
    Product Code
    GEX
    PMA / PMN Number
    K141851
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS SOLELY ATTRIBUTED TO USE ERROR AND THERE WAS NO DEVICE MALFUNCTION TO WARRANT INVESTIGATION OF THE DEVICE. THE DEVICE LABELING AND TRAINING MATERIALS WERE REVIEWED AND THERE WERE NO DEFICIENCIES IDENTIFIED. THE CUSTOMER WAS RETRAINED ON PROPER USE OF THE DEVICE AND THERE HAVE BEEN NO FURTHER ISSUES. ACCIDENTAL LASER BURN OF THE MACULA IS A KNOWN RISK OF THE PROCEDURE AND IS DESCRIBED IN: STANGA PE, MUQIT MM, MARCELLINO GR. MICROSTRUCTURAL CHANGES FOLLOWING INADVERTENT MULTI-SPOT LASER PHOTOCOAGULATION OF THE FOVEA. GRAEFES ARCH CLIN EXP OPHTHALMOL 2012;250(6):945-7. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2016, A PATIENT UNDERWENT RETINAL COAGULATION TREATMENT USING THE NAVILAS LASER SYSTEM. THE PATIENT HAD NO LIGHT PERCEPTION PREOPERATIVELY; IT SHOULD BE NOTED THAT THE TREATMENT WAS NOT BEING PERFORMED IN ORDER TO IMPROVE VISION, BUT RATHER TO MANAGE THE RISK OF NEOVASCULAR GLAUCOMA TO AVOID PAIN. DURING THE PROCEDURE THE PHYSICIAN INADVERTENTLY ACTIVATED THE FOOT PEDAL WHEN SHIFTING THE BASE TO THE LEFT WHEN THE PATTERN WAS NEAR THE MACULA. AS A RESULT, THE LASER TREATMENT WAS DELIVERED TO THE MACULA RATHER THAN TO THE DESIRED LOCATION ON THE RETINA. ALTHOUGH THE EVENT DID NOT RESULT IN VISUAL IMPAIRMENT (NOTING THE PREOPERATIVE VISUAL ACUITY), THE EVENT RESULTED IN PERMANENT DAMAGE TO THE MACULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831973 NAVILAS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX OD-OS GMBH 577+

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Disability