BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBER ONE

    MDR report key: 1920829 · Received December 9, 2010

    Report

    Report Number
    2937094-2010-01234
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 11, 2010
    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 THE CUSTOMER THAT ON (B)(6) 2010 THE FIBER END FIRED AT 15,419 JOULES. NO PT INJURY WAS REPORTED. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other