BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 2043542 · Received March 28, 2011

    Report

    Report Number
    2937094-2011-00459
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    AMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011, THE FIBER SHATTERED OUTSIDE OF THE PT UPON INSERTING THE FIBER IN THE FIBER PORT AT 0 JOULES. ALSO, IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH TURP. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT ADDSTAT SURGICAL FIBER GEX AMS, INNOVATION CENTER - SILICON VALLEY NA 036H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other