BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LADARVISION 4000

    MDR report key: 1133097 · Received August 22, 2008

    Report

    Report Number
    1061857-2008-00174
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 23, 2008
    Report Date
    July 23, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A SYSTEM OPERATOR REPORTS THE LASER STOPPED FIRING DURING SURGERY AND THE SYSTEM PRODUCED A LOW ENERGY MESSAGE. THE ABLATE BUTTON AND FOOTSWITCH WERE REPRESSED AND THE SURGERY WAS COMPLETED. THIS SYSTEM OPERATOR REPORTED THERE WERE 6 INTERRUPTIONS DURING SURGERY, HOWEVER INFORMATION INDICATES PATIENT OUTCOME WAS NOT AFFECTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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 NA