BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPHTHALAS 532 EYELITE LASER SYSTEM

    MDR report key: 1679470 · Received May 6, 2010

    Report

    Report Number
    2028159-2010-00595
    Event Type
    Malfunction
    Date Received
    May 6, 2010
    Date of Event
    April 6, 2010
    Report Date
    April 6, 2010
    Manufacturer
    ARELLANO, ALVIN OD (VS), FOCAL POINT OPTOMETRY
    Product Code
    GEX
    PMA / PMN Number
    K914334
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REP EXAMINED THE SYSTEM AND CONFIRMED THE PROBLEM REPORTED. THE SLIT LAMP FIBER WAS REPLACED AND SENT FOR IN-HOUSE EVAL. THE LIO WAS RECALIBRATED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B) (4). (B) (4). (B) (4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PT INJURY REPORTED" (NO CONSEQUENCES OR IMPACT TO PT). PRODUCT PROBLEM(S): "SYSTEM MESSAGE DISPLAYED" (DEVICE DISPLAYS ERROR MESSAGE). THE NURSE REPORTED A SYSTEM MESSAGE DISPLAYED DURING SURGERY. THE NURSE STATED THE SURGEON MADE AN INCISION AND THE PROBE WAS INSERTED INTO THE EYE. EVERY TIME THE SURGEON STEPPED ON THE FOOTSWITCH, A SYSTEM MESSAGE DISPLAYED. THE SYSTEM WAS SWITCHED OUT TO COMPLETE THE CASE. THERE WAS A 10 MINUTE DELAY. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPHTHALAS 532 EYELITE LASER SYSTEM LASER INSTRUMENT, SURGICAL, POWERED GEX ARELLANO, ALVIN OD (VS), FOCAL POINT OPTOMETRY 8065500001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK