BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH TRANS. FIBEROPTIC LIGHT GUIDE

    MDR report key: 543880 · Received April 2, 2004

    Report

    Report Number
    1519132-2004-00023
    Event Type
    Malfunction
    Date Received
    April 2, 2004
    Date of Event
    March 11, 2004
    Report Date
    April 2, 2004
    Manufacturer
    ACMI NORWALK
    Product Code
    EQH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    G93 FIBEROPTIC LIGHT GUIDE WAS LYING ON THE BED/TABLE. CUSTOMER WAS PUTTING ALL INSTRUMENTATION TOGETHER, CONNECTING THE G93 TO THE MV-9090 XENON LIGHT SOURCE WHEN SUDDENLY SMOKE STARTED COMING OUT FROM THE G93 LIGHT GUIDE. DOCTOR WAS 10 MINUTES AWAY FROM PERFORMING PROCEDURE. THERE IS NO PATIENT INVOLVEMENT AND THERE IS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIGH TRANS. FIBEROPTIC LIGHT GUIDE FIBEROPTIC LIGHT GUIDE EQH ACMI NORWALK G93 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN