BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT EX500 EXCIMER LASER

    MDR report key: 4863980 · Received June 23, 2015

    Report

    Report Number
    3003288808-2015-05729
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    May 25, 2015
    Report Date
    September 2, 2015
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P020050
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE FOUND BASED OFF OF REVIEW OF DEVICE HISTORY RECORDS. THE ROOT CAUSE COULD NOT BE IDENTIFIED CONCLUSIVELY. BASED ON INFORMATION RECEIVED FOLLOWING SUBMISSION OF THE INITIAL REPORT, THIS EVENT DOES NOT MEET CRITERIA FOR REPORTING AS A DEVICE MALFUNCTION. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WERE REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON ACCEPTANCE CRITERIA. INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A LASER PROCEDURE WAS ABORTED AT APPROXIMATELY EIGHTY PERCENT, DUE TO A SCANNER ERROR. CUSTOMER INFORMED THAT MULTIPLE SCANNER ERRORS WERE EXPERIENCED DURING SYSTEM BOOT UP. UPON ADDITIONAL FOLLOW UP, CUSTOMER REPORTED THAT THE PATIENT IS HAPPY WITH THE OUTCOME OF TREATMENT, AND THERE IS NO SECONDARY INTERVENTION PLANNED.

    Description of Event or Problem · 1

    UPON FOLLOW UP, THIS EVENT OCCURRED DURING BOOT UP AND ENERGY CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405353 WAVELIGHT EX500 EXCIMER LASER OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other