BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 2081089 · Received April 14, 2011

    Report

    Report Number
    2937094-2011-00688
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 29, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011 THE FIBER EXPLODED; THE FIBER TIP TURNED BLACK AND THERE WAS NO BEAM VISIBLE AT 80,000 JOULES. ALSO, IT WAS REPORTED THE FIBER DID NOT BREAK INSIDE OF THE PROSTATE. THE PROCEDURE WAS FINISHED USING A PV EQUIPMENT. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT ADDSTAT SURGICAL FIBER GEX AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY NA 038H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other