BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LADARVISION 4000 LASER

    MDR report key: 2180858 · Received July 7, 2011

    Report

    Report Number
    3003288808-2011-00208
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    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
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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). THIS REPORT WAS MAILED TO FDA ON: (B)(4) 2011. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTS THAT A PT WAS PREPPED FOR SURGERY, TOPICAL ANESTHETIC ADMINISTERED, FLAP CUT. HOWEVER, THE LASER WOULD NOT FIRE. THE CUSTOMER ATTEMPTED A REBOOT OF THE SYS, BUT THIS DID NOT FIX THE ISSUE. THE SURGERY WAS CANCELED. ADD'L INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR