BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEGABEAM GAS FIBER ASSEMBLY 1.8MM

    MDR report key: 142524 · Received January 8, 1998

    Report

    Report Number
    1222625-1998-00001
    Event Type
    Death
    Date Received
    January 8, 1998
    Date of Event
    September 26, 1997
    Report Date
    January 8, 1998
    Manufacturer
    CERAMOPTEC, INC.
    Product Code
    EWG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CO RECEIVED A MED WATCH REPORT FROM MEDICAL CENTER INDICATING THAT A PT HAD DIED DUE TO ANY AIR EMBOLUS DURING A BRONCHOSCOPY PROCEDURE USING AN ND:YAG LASER. THE LASER IS NOT MFG BY CERAMOPTEC. CERAMOPTEC MFR THE FIBER OPTIC DELIVERY SYSTEM THAT WAS USED DURING THE PROCEDURE. THE HOSPITALS REPORT INDICATED THAT THE AIR EMBOLISM IS A KNOWN COMPLICATION OF THIS PROCEDURE. THE HOSPITAL ALSO STATED THAT THE DEVICE DID NOT MALFUNCTION. ALTHOUGH CERMOPTEC DOES NOT BELIEVE ITS FIBER OPTIC SYSTEM CAUSED OR CONTRIBUTED TO THE PT DEATH, THE COMPANY IS REPORTING THIS INCIDENT TO FDA IN THE SPIRIT OF THE MDR REGULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEGABEAM GAS FIBER ASSEMBLY 1.8MM GAS COOLED FIBER OPTIC DELIVERY SYSTEM EWG CERAMOPTEC, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death