BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX-GUARD 272 LASER FIBER

    MDR report key: 6208987 · Received December 28, 2016

    Report

    Report Number
    6208987
    Event Type
    Malfunction
    Date Received
    December 28, 2016
    Date of Event
    November 4, 2016
    Report Date
    November 9, 2016
    Manufacturer
    KARL STORZ ENDOSCOPY AMERICA INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE LASER FIBER WAS CONNECTED TO THE LASER AND THE LASER WAS IN THE STAND-BY MODE. STAFF IN THE ROOM NOTICED A GREEN GLOW OUT OF THE MIDDLE PART OF THE FIBER. THE FIBER WAS DISCONNECTED FROM THE LASER, HANDED OFF THE STERILE FIELD AND SAVED. A NEW FIBER WAS OPENED TO THE STERILE FIELD AND WORKED WITHOUT INCIDENT. MANUFACTURER RESPONSE FOR LASER FIBER, FLEX-GUARD 272 LASER FIBER (PER SITE REPORTER): THE SALES REP WAS NOTIFIED BY OR MANAGER. REPORTER IS NOT AWARE OF RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860004 FLEX-GUARD 272 LASER FIBER LASER HOLMIUM GEX KARL STORZ ENDOSCOPY AMERICA INC. M11538

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR NO OTHER THERAPIES