BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY

    MDR report key: 2180847 · Received July 7, 2011

    Report

    Report Number
    2937094-2011-01420
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 14, 2011
    Manufacturer
    AMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011, THE FIBER CAP INNER SHEET DID NOT ROTATE IN ACCORDANCE WITH THE EXTERNAL SHEET AND IT GRADUALLY BROKE. PER THE CUSTOMER, THE PROCEDURE WAS ABLE TO BE COMPLETED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT MOXY SURGICAL FIBER GEX AMS, INNOVATION CENTER - SILICON VALLEY NA 108A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other