BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 2191464 · Received June 7, 2011

    Report

    Report Number
    2937094-2011-01174
    Event Type
    Malfunction
    Date Received
    June 7, 2011
    Date of Event
    December 16, 2010
    Report Date
    May 12, 2011
    Manufacturer
    AMERICAN MED SYSTEMS, INNOVATION CENTER - SILICONE VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2010 THE FIBER CAP DETACHED INSIDE OF THE PT AT 192-823 JOULES. PER THE CUSTOMER, THE FIBER CAP WAS RETRIEVED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT ADDSTAT SURGICAL FIBER GEX AMERICAN MED SYSTEMS, INNOVATION CENTER - SILICONE VALLEY NA 026H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other