BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTA II

    MDR report key: 2181891 · Received July 28, 2011

    Report

    Report Number
    1720381-2011-00037
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    June 25, 2011
    Report Date
    July 27, 2011
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K004006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REASONABLE ATTEMPTS WERE MADE BY TELEPHONE AND EMAIL TO OBTAIN FURTHER INFORMATION INCLUDING PATIENT'S VITAL HISTORY AND AGE, TREATMENT SETTINGS, REPORTED OUTCOME; HOWEVER, NO FURTHER INFORMATION WAS PROVIDED IN ADDITION TO THE INITIAL REPORT. AN EVALUATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL EXPERT FOUND THAT THE DEVICE PERFORMED TO MANUFACTURER'S SPECIFICATIONS. DEVICE MALFUNCTION IS NOT THE SUSPECTED ROOT CAUSE OF THE EVENTS REPORTED. A REVIEW OF DEVICE LABELING FOUND THAT RISKS TO TREATMENT ARE KNOWN AND OCCUR AT EXTREMELY LOW RATE OF TREATED POPULATION. A REVIEW BY A LUMENIS HEALTH PROFESSIONAL AND A GLAUCOMA SPECIALIST CONCLUDED THAT INSUFFICIENT INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TO DETERMINE A ROOT CAUSE. THE HEALTHCARE PROFESSIONAL CONCLUDED THAT SIMILAR TO MANY SURGICAL PROCEDURES SLT TREATMENT INVOLVES THE USE OF A NUMBER OF ASSOCIATED DEVICES AND MEDICATIONS AND THAT ANY OF THESE COULD TRANSMIT A VIRAL OR BACTERIAL INFECTION. ADDITIONALLY, THE HEALTHCARE PROFESSIONALS CONCLUDED THAT THE POSSIBILITY EXISTS THAT THE PATIENT WAS NOT AN APPROPRIATE CANDIDATE FOR THE PROCEDURE OR COULD HAVE HAD RELATED PREEXISTING CONDITIONS AND/OR SUBSEQUENT REACTIONS TO THE TREATMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO PATIENTS SUSTAINED KERATITIS POST SELECTIVE LASER TRABECULOPLASTY (SLT) TO THE EYES FOR TREATMENT OF GLAUCOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELECTA II ND:YAG; 532 NM WAVELENGTH GREEN LASER GEX LUMENIS, INC. SELECTA II UK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other