BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIGUIDE

    MDR report key: 584990 · Received November 3, 2004

    Report

    Report Number
    1225808-2004-00001
    Event Type
    Malfunction
    Date Received
    November 3, 2004
    Date of Event
    September 1, 2004
    Report Date
    November 3, 2004
    Manufacturer
    DIOMED, INC.
    Product Code
    MVG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS HAVING A PHOTODYNAMIC THERAPY OF THE ESOPHAGUS ENDOSCOPICALLY. ORIGINALLY BUT DUCTOSPACE WAS PLACED IN A TUBE. POST TREATMENT IT WAS NOTICED THE FIBER DIFFUSER WAS MISSING. THEY WERE NOT ABLE TO RETRIEVE THE PIECE. HOWEVER IT WAS VISUALIZED IN THE ESOPHAGUS UNDER FLOURO. A SECOND PROCEDURE IN TWO DAYS REVEALED BROKEN PIECE HAD PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIGUIDE PDT DIFFUSER OPTICAL FIBER MVG DIOMED, INC. * 040704

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other