BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBER ONE

    MDR report key: 1950068 · Received December 7, 2010

    Report

    Report Number
    2937094-2010-01195
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 8, 2010
    Manufacturer
    AMS, INNOVATION CENTER-SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 284,325 JOULES. ALSO, IT WAS REPORTED THAT THE FIBER CAP WAS RETRIEVED. NO PATIENT 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 041A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other