BEUDAMED
    FDA Adverse Event Summary report: N

    OMNIGUIDE BEAMPATH FIBER AND ADAPTER

    MDR report key: 1878995 · Received October 19, 2010

    Report

    Report Number
    3005350457-2010-00003
    Date Received
    October 19, 2010
    Date of Event
    September 16, 2010
    Report Date
    October 15, 2010
    Manufacturer
    OMNIGUIDE, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE OMNIGUIDE SYSTEM INCLUDES A LASER WAVEGUIDE ADAPTER AND A FLEXIBLE FIBER THAT IS ATTACHED TO A MEDICAL LASER. THE FIBER IS SINGLE USE DISPOSABLE AND THE ADAPTER A PIECE OF CAPITAL EQUIPMENT THAT IS ATTACHED TO LASER. IN THIS HOSP, THE OMNIGUIDE SYSTEM WAS ATTACHED TO A SHARPLAN LASER WHICH IS ONE OF THE RECOMMENDED SYSTEMS THAT IS COMPATIBLE WITH OUR PRODUCT. REFER TO THE IFU FOR THE ENT-L PRODUCT. THE FLEXIBLE WAVEGUIDE FIBER THAT WAS USED IN THE PROCEDURE, CATALOGUE # ENT-L, K070157, WAS DISCARDED AFTER THE PROCEDURE AND COULD NOT BE EVALUATED. AFTER THE INCIDENT, AN OMNIGUIDE SERVICE TECH WAS SENT TO THE HEALTHCARE FACILITY TO EVALUATE THE ADAPTER SYSTEM, SERIAL # (B)(4), K073409. THE SERVICE TECH REPORTED THAT THE ADAPTER WAS FUNCTIONING PROPERLY AND THE LASER BEAM WAS ALIGNED, IT MET ALL OF THE PARAMETERS THAT CONSTITUTED A PREVENTATIVE MAINTENANCE CHECK-UP. TRENDING OF THIS MDR DEMONSTRATED THAT THIS MDR IS NOT PART OF A TREND.

    Description of Event or Problem · 1

    A PT DEATH WAS REPORTED AT (B)(6) MEDICAL CENTER, ON (B)(6) 2010. AN OMNIGUIDE SALES REP WAS PRESENT FOR THE CASE AND REPORTED THE DEATH. AN OMNIGUIDE WAVEGUIDE FIBER, PRODUCT CODE ENT-L, K070157, WAS USED WITH AN OMNIGUIDE STERILE WAVEGUIDE ADAPTER SYSTEM, K073409, ATTACHED TO A SHARPLAN LASER. THIS WAS THE 21ST PROCEDURE THAT THE SURGEON USED THE OMNIGUIDE PRODUCT. THE SALES REP REPORTED THAT A SURGEON TRIED TO REMOVE A LEFT UPPER LIP HEMANGIOMA WITH AN ENT-L FIBER. THE SURGEON MADE AN INCISION AND PLACED THE FIBER IN THE INCISION IN A MANNER THAT IS CONTRAINDICATED IN THE IFU. THE PT'S LIP AREA EXPANDED DUE TO THE COOLING GAS THAT EXITS THROUGH THE FIBER. THE SURGEON IMMEDIATELY REMOVED THE FIBER AND MADE ANOTHER INCISION AND TRIED AGAIN WITH THE SAME RESULT. THE SURGEON STOPPED USING THE LASER AND USED ANOTHER MODALITY. THE LASER WAS USED FOR ONLY SECONDS. APPROXIMATELY 10 MINUTES LATER, IT WAS REPORTED THAT THE PT'S BLOOD PRESSURE STARTED TO DROP. A REQUEST WAS MADE FOR THE CAUSE OF DEATH AND THE HOSPITAL RESPONDED THAT THERE WAS NOT A REPORT FROM THE CORONER AT THIS TIME. IT CANNOT BE DETERMINED IF THE LASER USE WAS THE CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIGUIDE BEAMPATH FIBER AND ADAPTER LASER WAVEGUIDE GEX OMNIGUIDE, INC. ENT-L UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death