BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVELIGHT FS200 FEMTOSECOND LASER

    MDR report key: 2160896 · Received June 16, 2011

    Report

    Report Number
    3003288808-2011-00117
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    October 11, 2010
    Report Date
    October 11, 2010
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    GEX
    PMA / PMN Number
    K101006
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE ONSITE INVESTIGATION, THE SERVICE TECH UPDATED THE SOFTWARE. ROOT CAUSE WAS IDENTIFIED AS SOFTWARE RELATED. (B)(4).

    Description of Event or Problem · 1

    SURGEON REPORTS THE VACUUM DID NOT START AUTOMATICALLY. PUMP STARTS ON THE 2ND ATTEMPT. NO PATIENT HARM REPORTED AND NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WAVELIGHT FS200 FEMTOSECOND LASER OPHTHALMIC FEMTOSECOND LASER GEX WAVELIGHT GMBH FS200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1