BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTA II

    MDR report key: 2071946 · Received April 28, 2011

    Report

    Report Number
    1720381-2011-00016
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 28, 2010
    Report Date
    April 28, 2011
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K004006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS BECAME AWARE OF MULTIPLE ADVERSE EVENT REPORTS AFTER AN INTERNET USER GROUP DISCUSSION BEGAN REGARDING UNEXPECTED OUTCOMES TO SLT TREATMENT FOR GLAUCOMA. A REVIEW CONDUCTED BY LUMENIS CLINICAL GLAUCOMA EXPERTS CONCLUDED THE INCIDENCE RATE OF THESE REPORTS IS EXTREMELY LOW AND DO NOT AFFECT THE RISK LEVEL OF THE TREATMENT. 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 INFORMATION IN THE ORIGINAL REPORT. NO DEVICE MALFUNCTION WAS REPORTED; THEREFORE, NO DEVICE EXAMINATION OCCURRED. TO THE BEST KNOWLEDGE OF LUMENIS, THE DEVICE REMAINS IN USE AT THE USER FACILITY. A REVIEW OF DEVICE LABELING FOUND THAT RISKS TO TREATMENT ARE KNOWN AND OCCUR AT AN 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 PROFESSIONALS 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 PATIENTS WERE NOT APPROPRIATE CANDIDATES FOR THE PROCEDURE OR COULD HAVE HAD SUBSEQUENT REACTIONS TO THE TREATMENTS. NO MALFUNCTION REPORTED/SUSPECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUB-EPITHELIAL INFILTRATE AND PROBABLE INFLAMMATION POST SELECTIVE LASER TRABECULOPLASTY (SLT) TO THE EYES FOR TREATMENT OF GLAUCOMA AND THAT THE PATIENT WAS ADMINISTERED TOPICAL STEROIDS TO PRECLUDE PERMANENT IMPAIRMENT. IT WAS FURTHER REPORTED THE PATIENT HAD HEALED WITH NO PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELECTA II ND:YAG PHOTOCOAGULATOR GEX LUMENIS, INC. SELECTA II

    Patients

    Seq Age Sex Outcome Treatment
    1 Other