BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY

    MDR report key: 2180824 · Received July 7, 2011

    Report

    Report Number
    2937094-2011-01421
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 15, 2011
    Manufacturer
    AMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011, THE FIBER CAP DETACHED WHILE INSIDE OF THE PT. PER THE CUSTOMER, ALL FIBER PIECES WERE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT MOXY SURGICAL FIBER GEX AMS, INNOVATION CENTER - SILICON VALLEY NA 115A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other