BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LADARVISION 4000

    MDR report key: 1060130 · Received June 11, 2008

    Report

    Report Number
    1061857-2008-00075
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    October 10, 2006
    Report Date
    October 12, 2006
    Manufacturer
    ALCON - ORLANDO TECHNOLOGY CENTER
    Product Code
    LZS
    PMA / PMN Number
    P970043
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTING OF THIS COMPLAINT AT THIS TIME IS BASED ON RECEIPT OF A LETTER FROM THE FDA DATED 4/10/08 IN WHICH THE AGENCY INFORMED ALCON THAT COMPLAINT (EVENT DATE: 2006) SHOULD HAVE BEEN REPORTED AS A SERIOUS INJURY MDR. AS A RESULT OF THAT INJURY REPORT, A 2-YEAR REPORTING TIMEFRAME WAS INITIATED FOR ALL COMPLAINTS OF THE SAME TYPE. ALL COMPLAINT FILES FOR THE LADARVISION4000 WERE REVIEWED FOR THIS TYPE OF EVENT STARTING 2006. THIS MDR FILING IS A RESULT OF THAT RETROSPECTIVE REVIEW. DETERMINATION OF ROOT CAUSE: ASSESSEMENT: WHILE ON SITE, THE FIELD SVC ENGINEER (FSE) WAS UNABLE TO REPRODUCE THE LASER NOT FIRING; HOWEVER, HE WAS ABLE TO CONFIRM THE EVENT DURING A REVIEW OF THE SURGERY DATABASE. THE FSE ALSO PERFORMED A SUCCESSFUL SYSTEM VERIFICATION. THIS SYSTEM IS NOT USED VERY OFTEN, SO THE ENERGY DROPS DOWN RATHER QUICKLY. THE FSE INSTRUCTED THE SURGEON AND THE SYSTEM OPERATOR TO CHECK THE ENERGY LEVEL WHEN A CALIBRATION IS PERFORMED. AS THE THYRATRON VOLTAGE NEARS 5V, A GAS FILL IS REQUIRED TO BRING UP THE ENERGY LEVEL. THE SYSTEM OPERATOR AND SURGEON INDICATED THEY WOULD PERFORM A GAS FILL AND A PASSIVATION CYCLE ONE DAY BEFORE EACH SURGERY DAY TO ENSURE THE LASER OUTPUT IS MORE STABLE/STRONGER. CONCLUSION: BASED ON THE RESULTS ON THIS INVESTIGATION, THE ROOT CAUSE IS COMPONENT RELATED, SPECIFICALLY DUE TO LOW ENERGY FROM THE LASER CARTRIDGE.

    Description of Event or Problem · 1

    A SURGEON REPORTS THE LASER STOPPED FIRING 66% INTO A PROCEDURE ON THE RIGHT EYE. DURING THE INITIAL PHONE CALL FROM THE FACILITY, THE FIELD SVC ENGINEER (FSE) INSTRUCTED THE FACILITY TO PERFORM A CONFIGURE LASER TEST. FOLLOWING THAT, THE CONTROL VOLTAGE WAS 5V AND ENERGY OUTPUT WAS TOO LOW. THE SYSTEM REQUIRED A GAS CHANGE. AFTER THE GAS CHANGE, THE CONTROL VOLTAGE WAS 4.43V. THE REMAINING PART OF THE PROCEDURE ON THE RIGHT EYE WAS COMPLETED SUCCESSFULLY. THIS PT WAS REFERRED TO THIS SURGEON FOR THE LASIK PROCEDURE AND THE SURGEON HAS NOT SEEN THE PT FOR FOLLOW-UP. THE SURGEON DID STATE HE FELT SURE THAT IN CASE OF ANY PROBLEMS, HE WOULD CERTAINLY HAVE BEEN NOTIFIED. THE SURGEON HAS RECEIVED NO FOLLOW-UP INFO REGARDING THIS PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LADARVISION 4000 OPHTHALMIC EXCIMER LASER SYSTEM LZS ALCON - ORLANDO TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK