BEUDAMED
    FDA Adverse Event Death Summary report: N

    VERSAPULSE POWERSUITE 20W

    MDR report key: 806228 · Received January 19, 2007

    Report

    Report Number
    2914019-2006-00119
    Event Type
    Death
    Date Received
    January 19, 2007
    Date of Event
    November 3, 2006
    Report Date
    January 19, 2007
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE LUMENIS REPRESENTATIVE, A SLIMLINE 365 DELIVERY DEVICE WAS TAKEN NEW OUT OF THE BOX FOR THIS PROCEDURE. THE SLIMLINE 365 IS A REUSABLE FIBER OPTIC DELIVERY DEVICE. LUMENIS HAS REQUESTED THAT THE DELIVERY DEVICE BE RETURNED TO LUMENIS FOR EVALUATION. LUMENIS HAS REQUESTED ADDITIONAL PATIENT AND INCIDENT DETAILS FROM THE PHYSICIAN. LUMENIS SERVICE IS SCHEDULED TO EVALUATE THE POWERSUITE DEVICE. A FOLLOW-UP MEDWATCH REPORT WILL BE FILED WITH DEVICE EVALUATION AND ROOT CAUSE ANALYSIS. PER THE LUMENIS INVESTIGATION, LUMENIS REPRESENTATIVES WERE PRESENT AT THE CUSTOMER LOCATION DURING THE PROCEDURE. THE LUMENIS REPRESENTATIVES WERE INFORMED THAT THE PATIENT HAD EXPERIENCED A COMPLICATION THAT WAS NOT RELATED TO THE LUMENIS DEVICES. THE LUMENIS REPRESENTATIVES WERE NO LONGER AT THE HOSPITAL WHEN THEY WERE NOTIFIED BY THE PHYSICIAN THAT THE PATIENT HAD EXPIRED. THE LUMENIS REPRESENTATIVES STATED THAT THEY DID NOT BELIEVE THAT THE INCIDENT WAS A SAFETY COMPLAINT BECAUSE THEY HAD BEEN INFORMED BY THE PHYSICIAN THAT THE INCIDENT WAS NOT RELATED TO THE LUMENIS DEVICES; THEREFORE, THE INCIDENT WAS NOT FORMALLY REPORTED AS A SAFETY INCIDENT. LUMENIS REGULATORY IS CONTINUING TO INVESTIGATE. A LUMENIS EMPLOYEE BROUGHT THE INCIDENT TO THE ATTENTION OF LUMENIS REGULATORY ON 1/15/2007, THEREFORE, A 5 DAY REPORT IS BEING FILED.

    Description of Event or Problem · 1

    THIS INCIDENT WAS REPORTED TO LUMENIS REGULATORY ON 01/15/2007. FOLLOWING COMPLETION OF A LASER ABLATION PROCEDURE, A PATIENT HAD A COMPLICATION AND EXPIRED LATER ON THE DAY OF THE PROCEDURE. PER THE TREATING PHYSICIAN, THE INCIDENT WAS NOT RELATED TO THE LUMENIS DEVICE. LUMENIS SERVICE IS SCHEDULED TO EVALUATE THE POWERSUITE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSAPULSE POWERSUITE 20W HO:YAG SURGICAL LASER GEX LUMENIS, INC. POWERSUITE 20W *

    Patients

    Seq Age Sex Outcome Treatment
    1 Death REQUESTED AND PENDING