BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVUS 2000

    MDR report key: 588062 · Received April 5, 2005

    Report

    Report Number
    1720381-2005-00003
    Event Type
    Injury
    Date Received
    April 5, 2005
    Date of Event
    February 7, 2005
    Report Date
    April 1, 2005
    Manufacturer
    LUMENIS, INC. (FORMERLY COHERENT)
    Product Code
    HQB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED A FULL-THICKNESS RETINAL BURN WHEN THE PHYSICIAN, WHO WAS ACCUSTOMED TO TREATING AT A SETTING OF 100 MW, DID NOT REALIZE THAT THE POWER SETTING RETAINED IN MEMORY FROM THE PRIOR CASE (1000 MW) CONTAINED A FOURTH DIGIT. OTHER TREATMENT PARAMETERS WERE 100 MICRON SPOT SIZE, 0.1 SECOND DURATION. THE PHYSICIAN PERFORMED A SINGLE PARAFOVEAL TEST SHOT (OFF-CENTER) AT THE 1000 MW AND, IMMEDIATELY REALIZING THE HIGH SETTING, SUSPENDED THE TREATMENT. THE PT IS BEING FOLLOWED FOR THE RETINAL BURN. PER THE PHYSICIAN, PRE-INCIDENT VISUAL ACUITY WAS NEARLY 20-20 BASED ON STANDARD SNELLEN TEST; POST-INCIDENT SNELLEN TEST PER THE PHHYSICIAN APPEARS AT THIS TIME NOT TO HAVE CHANGED FROM BASELINE. VISUAL FIELD TEST IS PENDING WITHIN THE NEXT MONTH AND WILL INDICATE THE PRESENCE AND SEVERITY OF ANY DECREMENT TO PERIPHERAL VISION. "LASER POWER SET TOO HIGH (1000MW INSTEAD OF 100MW) FOR THE REQUIRED RERTINAL PHOTOCOAGULATION TREATMENT. THIS ERROR AROSE OUT OF LASER HAVING BEEN USED BY A PREVIOUS OPERATOR AT MUCH HIGHER POWER THAN IS USUAL. POWER SETTINGS REMAINED IN LASER SOFTWARE MEMORY FROM PREVIOUS TREATMENT DESPITE SHUTTING DOWN THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVUS 2000 OPHTHALMIC LASER HQB LUMENIS, INC. (FORMERLY COHERENT) * *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other INFORMATION REQUESTED AND PENDING.