BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVUS VARIA

    MDR report key: 771749 · Received August 11, 2006

    Report

    Report Number
    1720381-2006-00001
    Event Type
    Malfunction
    Date Received
    August 11, 2006
    Date of Event
    July 6, 2006
    Report Date
    August 11, 2006
    Manufacturer
    LUMENIS
    Product Code
    HQF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS EVALUATED THE SYSTEM FIVE DAYS LATER. PER THE CE, THERE WERE HIGH/LOW ERRORS ABOVE 900 MW GREEN AND THE SYSTEM WAS OUT OF CALIBRATION. THIS APEARS TO BE THE ROOT CAUSE OF THE INCIDENT. DEVICE WAS REPAIRED AND CALIBRATED.

    Description of Event or Problem · 1

    PER CUSTOMER, DURING A PRP PANRETINAL PHOTOCOAGULATION PROCEDURE, THE FIRST EYE WAS TREATED WITHOUT INCIDENT AND THE PT COMPLAINED OF PAIN DURING TREATMENT OF THE SECOND EYE. THE PHYSICIAN SAW THE ERROR CODE (INTERMITTENT MESSAGE OF 20% HIGH POWER OUTPUT USING THE GREEN LASER) AND INTERRUPTED THE PROCEDURE. PER THE PYSICIAN, THE PT WAS NOT INJURED, AND THE PROGNOSIS IS FINE. THERE WAS NO MEDICAL INTERVENTION. THE PT IS SCHEDULED TO RETURN TO COMPLETE THE PRP ON THE SECOND EYE. PER THE PHYSICIAN, THERE IS NO HARM OR CONSEQUENCE TO THE PT FROM COMPLETING THE PROCEDURE TO THE SECOND EYE IN TWO SITTINGS. SERVICE CALL SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVUS VARIA ND: YAG PHOTOCOAGULATOR HQF LUMENIS 0642-000-01 *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other NONE REPORTED