BEUDAMED
    FDA Adverse Event Other Summary report: N

    VASCULIGHT

    MDR report key: 970807 · Received April 30, 2007

    Report

    Report Number
    2914019-2003-00019
    Event Type
    Other
    Date Received
    April 30, 2007
    Date of Event
    January 1, 2003
    Report Date
    April 30, 2007
    Manufacturer
    LUMENIS LTD
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER. THERE IS NO RECORD THAT THE CUSTOMER HAS PREVIOUSLY REPORTED ANY 2003 SAFETY INCIDENT TO LUMENIS. AS THIS DEVICE WAS EVALUATED BY LUMENIS SERVICE AFTER THE DATE OF THE ALLEGED INCIDENT, NO ADD'L DEVICE EVALUATION IS INDICATED FOR INVESTIGATION PURPOSES. THE CUSTOMER REPORTED A PROBLEM WITH THE DEVICE COOLING SYSTEM ON 12/30/2004; THE LUMENIS CE EVALUATED THE VASCULIGHT DEVICE AND REPLACED THE COOLING SYSTEM ASSEMBLY. THE CE PERFORMED HEAD ENERGY TEST ON ALL THREE TREATMENT HEADS, AND ALL THREE TREATMENT HEADS TESTED WITHIN SPECIFICATION. WITHOUT ADD'L DETAILS, NO CONCLUSION CAN BE DRAWN AS TO THE RELEVANCE OF THE DEVICE PROBLEM DOCUMENTED IN SERVICE REPORT TO THE ALLEGED SAFETY INCIDENT. LUMENIS REGULATORY HAS INITIATED MULTIPLE CONTACTS TO THE CUSTOMER REP AND AS OF 04/26/2007, LUMENIS HAS NOT BEEN PROVIDED PT AND INCIDENT DETAILS FOR INVESTIGATION. WITHOUT ADD'L INFO, NO CONCLUSION CAN BE DRAWN REGARDING THE ROOT CAUSE OF THE INCIDENT. IF SIGNIFICANT ADD'L DETAILS ARE OBTAINED IN THE FUTURE BY LUMENIS, A FOLLOW-UP MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CUSTOMER REP REPORTED A SAFETY INCIDENT THAT IS ALLEGED TO HAVE OCCURRED IN 2003 IN ASSOCIATION WITH TREATMENT WITH THE SUBJECT VASCULIGHT SR DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other