BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTA II

    MDR report key: 2071949 · Received April 28, 2011

    Report

    Report Number
    1720381-2011-00019
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    September 22, 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
    PA, 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. 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 EXTREMELY LOW RATE OF TREATED POPULATION. A REVIEW OF THE REPORTED EVENT DETAILS AND CLINICAL NOTES-- SUBMITTED BY THE DEVICE OPERATOR--BY A LUMENIS HEALTH PROFESSIONAL AND A GLAUCOMA SPECIALIST CONCLUDED THE PROBABLE ROOT CAUSE TO BE MILD INFLAMMATION (WHICH IS NOTED IN SOME PATIENTS AND NOT CONSIDERED A SEVERE ADVERSE EVENT) WITH AN ASSUMPTION OF A LOW ENDOTHELIAL CELL COUNT IN THE EYE, RESULTING IN THE REPORTED PBK. THE HEALTHCARE PROFESSIONALS ADDITIONALLY 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 AND/OR COULD HAVE HAD RELATED PREEXISTING CONDITIONS OR SUBSEQUENT REACTIONS TO THE TREATMENTS. NO DEVICE MALFUNCTION REPORTED/SUSPECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUSTAINED PSEUDOPHAKIC BULLOUS KERATOPATHY (PBK) TO THE LEFT EYE POST SELECTIVE LASER TRABECULOPLASTY (SLT) TO THE EYES FOR TREATMENT OF GLAUCOMA. IT WAS FURTHER REPORTED THAT THE PATIENT EXHIBITED A LOW ENDOTHELIAL COUNT IN THE RIGHT EYE. IT WAS FURTHER REPORTED THAT THE CLINICIAN DOES NOT EMPLOY POST-OPERATIVE ANTI-INFLAMMATORY DROPS (NSAID OR STEROID). IT WAS FURTHER REPORTED THE PATIENT'S ELEVATED IOP WAS WELL CONTROLLED AFTER SLT WITH GRADUAL CLEARING OF THE CORNEA.

    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 84 YR Other