BEUDAMED
    FDA Adverse Event Other Summary report: N

    VASCULIGHT

    MDR report key: 829851 · Received March 9, 2007

    Report

    Report Number
    2914019-2004-00032
    Event Type
    Other
    Date Received
    March 9, 2007
    Report Date
    March 9, 2007
    Manufacturer
    LUMENIS LTD
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT AVAILABLE FOR EVAL BY LUMENIS. THE CUSTOMER HAD NOT REQUESTED SERVICE FOR THIS VASCULIGHT ELITE DEVICE SINCE INSTALLATION ON 12/04/2003. CUSTOMER DID NOT RESPOND TO REQUESTS FROM LUMENIS TO PROVIDE DETAILS FOR INVESTIGATION. IN THE ORIGINAL ANALYSIS, THIS INCIDENT WAS DETERMINED BY LUMENIS NOT TO BE MDR REPORTABLE. THIS INCIDENT WAS LATER RECLASSIFIED BY LUMENIS AS MDR REPORTABLE AS A RESULT OF AN INTERNAL AUDIT AND THE FDA LETTER DATED JULY, 25, 2006.

    Description of Event or Problem · 1

    THE LUMENIS CLINICAL TRAINER LEARNED THAT A PT HAS ALLEGED INJURIES ASSOCIATED WITH AN NDYAG LASER TREATMENT PERFORMED AT THIS CUSTOMER LOCATION. NO INCIDENT DATE WAS REPORTED, HOWEVER, THE INCIDENT MAY HAVE OCCURRED IN SUMMER, 2004. LUMENIS CONTACTED THE CUSTOMER FOR INCIDENT AND PT DETAILS AND THE CUSTOMER DID NOT PROVIDE THE REQUESTED INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASCULIGHT COMBINATION INTENSE PULSE LIGHT DEVICE AND SOLID STATE LASER GEX LUMENIS LTD VASCULIGHT ELITE *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other REQUESTED AND NOT PROVIDED.