BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBER ONE

    MDR report key: 1970969 · Received January 6, 2011

    Report

    Report Number
    2937094-2010-01530
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 15, 2010
    Report Date
    December 16, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, 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 THE CUSTOMER THAT ON (B)(6) 2010, THE FIBER CAP DETACHED AT 0 JOULES. ALSO, IT WAS REPORTED THAT THERE WAS AN EXCESSIVE PUSH INTO THE SMALL WORKING CHANNEL. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIBER ONE SURGICAL FIBER GEX AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY NA 042A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other