BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GERACI/MILLER SMOKE EVACUATION

    MDR report key: 47669 · Received October 24, 1996

    Report

    Report Number
    47669
    Event Type
    Malfunction
    Date Received
    October 24, 1996
    Date of Event
    October 18, 1996
    Report Date
    October 24, 1996
    Manufacturer
    LASE, INC.
    Product Code
    FCZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAVING EGD WHEN LASER SMOKE EVACUATOR FAILED. PROCEDURE TERMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GERACI/MILLER SMOKE EVACUATION LASER SMOKE EVACUATOR FCZ LASE, INC. SE11111 B11 *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other