BEUDAMED
    FDA Adverse Event Death Summary report: N

    GAS FIBER ASEMBLY 1.8 MILIMETER

    MDR report key: 141329 · Received January 2, 1998

    Report

    Report Number
    141329
    Event Type
    Death
    Date Received
    January 2, 1998
    Date of Event
    September 26, 1997
    Report Date
    December 30, 1997
    Manufacturer
    CERAMOPTIC
    Product Code
    EWG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AIR EMBOLUS DURING YAG LASER BRONCHOSCOPY. THIS WAS NOT A DEVICE MALFUNCTION. THIS REPORT DESCRIBED AN AIR EMBOLUS WHICH OCCURRED DURING A YAG LASER BRONCHOSCOPY AND WHICH RESULTED IN A PT DEATH. AIR EMBOLISM IS A KNOWN COMPLICATION OF THIS PROCEDURE. THE ETIOLOGY OF AIR EMBOLISM WAS NOT UNDERSTOOD UNTIL SOME RECENT RESEARCH WHICH WAS CONDUCTED BY A GROUP FROM YALE. THE RESULTS OF THIS RESEARCH ARE SO NEW THAT THEY ARE NOT YET PUBLISHED. A PAPER IS EXPECTED TO BE PUBLISHED ON THIS TOPIC SOON. THE RESEARCH SUGGESTS THAT A CHANGE IN TECHNIQUE IN THE USE OF THE YAG LASER IN THIS PROCEDURE WILL REDUCE THE LIKELIHOOD OF EXPERIENCING THIS COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAS FIBER ASEMBLY 1.8 MILIMETER GAS COOLED LASER FIBER EWG CERAMOPTIC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death