BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE

    MDR report key: 2890977 · Received December 21, 2012

    Report

    Report Number
    3003288808-2012-00527
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 16, 2012
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WERE REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY'S ACCEPTANCE CRITERIA. DURING THE REQUESTED ON-SITE VISIT, THE FIELD SERVICE ENGINEER VERIFIED SYSTEM OPERATION PER E-STP (ELECTRONIC SERVICE TEST PROCEDURES). A REVIEW OF THE TECHNICAL SERVICE ON-SITE SHOWED NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT. LASER WAS SUCCESSFULLY VERIFIED PRIOR TO, AND AFTER THE DAY OF THE EVENT. LOGFILE REVIEW OF THE DATE OF EVENT CONFIRMED TREATMENT WAS INTERRUPTED, AND THE SYSTEM MESSAGE WAS RECEIVED. THE SYSTEM MESSAGE WAS NOT INFLUENCED BY THE DEVICE, BUT BY THE WAY IT WAS USED. THE FOOTPEDAL HAS TWO SENSORS: ONE FOR LASER FIRING AND ONE FOR SHUTTER OPENING. IF PEDAL RELEASE IS TOO SLOW, IT COULD LEAD TO SHUTTER FLAG CLOSURE AFTER WHICH THE LASER WOULD SHOOT AGAINST THE FLAG, LEADING TO A SHUTTER ERROR. ROOT CAUSE WAS ASSESSED TO BE USER ERROR, THE SURGEON HESITATING AND THEN RELEASING THE FOOTPEDAL, WHICH CAUSED THE SYSTEM MESSAGE. (B)(4).

    Description of Event or Problem · 1

    A TECHNICIAN REPORTED THAT DURING A PATIENT'S LASER TREATMENT, THE LASER STOPPED FIRING AT 81%. A SYSTEM MESSAGE WAS DISPLAYED INDICATING THERE WAS A SHUTTER ERROR, AND THE LASER WAS REBOOTED. UPON FOLLOW UP, THE TECHNICIAN STATED THAT THE CASE INVOLVED WAS A PRK (PHOTO REFRACTIVE KERATECTOMY) TREATMENT, AND DURING THE PROCEDURE THE SURGEON WAS HESITATING ON THE LASER FOOT PEDAL, BECAUSE THE PATIENT WAS HAVING A HARD TIME FOCUSING ON THE FIXATION LIGHT. SURGEON WAS STATED TO HAVE REMOVED HER FOOT FROM THE PEDAL DURING TREATMENT, AFTER WHICH THE SYSTEM MESSAGE DISPLAYED. REPORTER CALLED FOR SUPPORT, AND MENTIONED THAT THERE WAS A 45 MINUTE TO ONE HOUR DELAY IN THE PROCEDURE, WHILE TROUBLE SHOOTING, DURING WHICH TIME THE PATIENT HAD THE EYE CLOSED. PROCEDURE WAS NOTED TO HAVE BEEN COMPLETED. DATA RECEIVED SHOWED THAT THE PLANNED OUTCOME WAS PLANO, AND THE POST OPERATIVE REFRACTIVE MEASUREMENT, AFTER TWO AND A HALF MONTHS, REFLECTED A CAUSE OF INDUCED ASTIGMATISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGRETTO WAVE OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other NONE REPORTED.