BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LADARVISION 4000

    MDR report key: 1060011 · Received June 12, 2008

    Report

    Report Number
    1061857-2008-00071
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    January 4, 2008
    Report Date
    January 4, 2008
    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
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTING OF THIS COMPLAINT AT THIS TIME IS BASED ON RECEIPT OF A LETTER FROM THE FDA DATED APRIL 10, 2008 IN WHICH 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 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 FOUND THE SYSTEM WOULD NOT COME OUT OF 'LASER NOT READY' STATE. HE FOUND NO POWER TO THE HIGH VOLTAGE POWER SUPPLY (HVPS) DUE TO A LOOSE P1 CONNECTOR BETWEEN THE HVPS AND THE LASER CONTROL ELECTRONICS. HE RESEATED THE CONNECTOR AND COMPLETED A SYSTEM VERIFICATION PRIOR TO DEPARTURE. CONCLUSION: BASED ON THE RESULTS OF THE INVESTIGATION THE ROOT CAUSE OF THE REPORTED DIFFICULTY WAS DUE TO A LOOSE CONNECTOR. THIS REPORT MAILED IN TO FDA ON: 06/12/2008.

    Description of Event or Problem · 1

    A NURSE REPORTS THE LASER STOPPED FIRING 13% INTO A PROCEDURE AND AN ERROR MESSAGE, LASER NOT READY, WAS DISPLAYED. THE SURGERY COULD NOT BE COMPLETED. FOLLOW-UP INFO FROM THE REPORTER INDICATES THE PT'S SURGERY WAS COMPLETED THE FOLLOWING WEEK AND THE PT WAS NOT HARMED OR INJURED BY THE 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