BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 2081093 · Received April 14, 2011

    Report

    Report Number
    2937094-2011-00703
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 31, 2011
    Report Date
    March 31, 2011
    Manufacturer
    AMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011, THE FIBER BROKE AT 0 JOULES. ALSO, IT WAS REPORTED THE FIBER BREAK WAS NOTICED AFTER THE FIBER WAS ATTACHED TO THE LASER. PER THE CUSTOMER, THE BREAK WAS PROXIMAL TO THE LASER ATTACHMENT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT ADDSTAT SURGICAL FIBER GEX AMS, INNOVATION CENTER - SILICON VALLEY NA 105A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other