BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPECTRA, INTEGRATED

    MDR report key: 723806 · Received June 7, 2006

    Report

    Report Number
    2914019-2006-00047
    Event Type
    Other
    Date Received
    June 7, 2006
    Date of Event
    May 8, 2006
    Report Date
    June 7, 2006
    Manufacturer
    LUMENIS
    Product Code
    HQF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2006 (CO191729) A DEMO SPECTRA SYSTEM WAS INSTALLED WHILE THE CUSTOMER SPECTRA SYSTEM WAS SERVICED IN THE SVC DEPOT. THE LUMENIS CUSTOMER ENDINEER (CE) INSTALLED THE DEMO SYSTEM WILL THE CUSTOMER'S OWN SLITLAMP. THE CUSTOMER STATED TO THE CE THAT CUSTOMER WOULD PREFER TO PURCHASE AND INTALL A HAAG-STREIT SLIT LAMP, WHICH IS COMPATIBLE WITH THE SPECTRA. THE CE RECOMMENDED TO THE CUSTOMER THAT IF THE CUSTOMER DID HAVE A HAAG-STREET SLIT CLAMP INSTALLED, THE CUSTOMER SHOULD CALL LUMENIS TO HAVE THE LUMENIS CE VERIFY THE INSTALLATION OF THE HAAG-STRELL SLIT LAMP, IN A SUBSEQUENT SVC CALL, PRIOR TO USING THE MODIFIED SYSTEM FOR TREATMENTS. THAT SAME DAY, THE PHYSICIAN REPORTED TO LUMENIS THAT HE HAD PURCHASED THE HAAG-STREIT SLIT LAMP, THAT THE HAAG-STREIT REP AHD INSTALLED THE NEW HAAG-STREIT SLIT LAMP, AND THAT WHILE DOING THE FIRST CASE WITH THE MODIFIED SYSTEM THIRTEEN DAYS LATER, THE PHYSICIAN HAD EXPERIENCED A MINOR BURN TO ONE EYEKIT. "THE PHYSICIAN ACKNOWLEDGED THAT HE HAD NOT DONE AS RECOMMENDED BY LUMENIS, CALLED LUMENIS TO HAVE THE INSTALLATION OF THE HAAG-STREIT SLIT LAMP VERIFIED PRIOR TO PERFORMING CASES WITH THE MODIFIED SYSTEM. SVC CALL C0192386 WAS OPENED TO INVESTIGATE THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRA, INTEGRATED OPHTHALMIC LASER HQF LUMENIS 0642-510-01 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other