BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LADARVISION 4000

    MDR report key: 1060009 · Received June 12, 2008

    Report

    Report Number
    1061857-2008-00069
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    December 27, 2007
    Report Date
    December 27, 2007
    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
    TX, US
    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 APRIL 10, 2008 IN WHICH AGENCY INFORMED ALCON THAT (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 LADARVISION 4000 WERE REVIEWED FOR THIS TYPE OF EVENT STARTING 2006. THIS MDR FILING IS A RESULT OF THAT RETROSPECTIVE REVIEW. DETERMINATION OF ROOT CAUSE: ASSESSMENT: THE TECHNICAL MANAGER (TM) WAS DISPATCHED TO THE SITE TO EVALUATE THE DEVICE AND WAS ABLE TO CONFIRM THE LASER NOT FIRING THROUGH THE SURGERY DATABASE. THE LASER WOULD NOT CONFIGURE UPON ARRIVAL AND THE TM REPLACED THE CHASSIS. HE COMPLETED A SYSTEM VERIFICATION PRIOR TO DEPARTURE. THE RETURNED PART WAS TESTED BY MANUFACTURING, AND THE CHASSIS WAS FOUND TO BE FAULTY. CONCLUSION: BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE IS RELATED TO A FAULTY LASER CHASSIS.

    Description of Event or Problem · 1

    A SYSTEM OPERATOR REPORTS THE LASER STOPPED FIRING 24% INTO A PROCEDURE. SHE WAS ABLE TO ABORT THE PROCEDURE, RE-ENTER AND WAS ABLE TO PROCEED. THE SURGEON STATED THE PT WAS NOT HARMED OR INJURED BY THIS EVENT.

    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