BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIGUIDE

    MDR report key: 1157823 · Received August 22, 2008

    Report

    Report Number
    1157823
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 22, 2008
    Manufacturer
    DIOMED, INC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE SPYGLASS ERCP PROCEDURE OF THE CBD WITH THE PDT PROBE, THE TIP OF THE FIBER BROKE OFF IMMEDIATELY PROXIMAL TO THE BIFURCATION. APPROXIMATELY 1 CM OF THE GLASS TIP REMAINS IN THE CBD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIGUIDE FIBER, LASER GEX DIOMED, INC DCYL 210 4102001

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR