BEUDAMED
    FDA Adverse Event Death Summary report: N

    VERSAPULSE DUAL 80/100

    MDR report key: 640439 · Received October 11, 2005

    Report

    Report Number
    2914019-2005-00045
    Event Type
    Death
    Date Received
    October 11, 2005
    Date of Event
    October 3, 2005
    Report Date
    October 11, 2005
    Manufacturer
    COHERENT MEDICAL GROUP
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REQUESTED SERVICE IN 10/2005 TO CHECK PROPER OPERATIONS OF THE VERSAPULSE SELECT UNIT. CUSTOMER BIOMEDICAL ENGINEERING DEPARTMENT INFORMED LUMENIS SERVICE IN ADVANCE THAT A PT HAD EXPIRED DUE TO A SURGICAL COMPLICATION IN ASSOCIATION WITH A CASE PERFORMED WITH A VERSAPULSE SELECT. LUMENIS FIELD SERVICE EVALUATED THE VERSAPULSE SELECT 5 DAYS LATER AND FOUND THE VERSAPULSE SELECT, TO BE OPERATING WITHIN SPECIFICATION. LUMENIS HAS REQUESTED FROM THE HOSPITAL ADDITIONAL INFORMATION REGARDING THE PT, PROCEDURE, CAUSE OF DEATH AND LASER FIBER USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSAPULSE DUAL 80/100 SURGICAL LASERS GEX COHERENT MEDICAL GROUP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death| R