BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS

    MDR report key: 2608794 · Received May 25, 2012

    Report

    Report Number
    2608794
    Event Type
    Malfunction
    Date Received
    May 25, 2012
    Date of Event
    May 21, 2012
    Report Date
    May 25, 2012
    Manufacturer
    AMS INNOVATION CENTER-SILICON VALLEY
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US

    Narratives

    Description of Event or Problem · 1

    GREENLIGHT HPS LASER FIBER FAILED DURING PROCEDURE. A SECOND FIBER WAS OBTAINED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT HPS LASER FIBER, SURGICAL GEX AMS INNOVATION CENTER-SILICON VALLEY 10-2090 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *