BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 2062265 · Received April 12, 2011

    Report

    Report Number
    2937094-2011-00622
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 16, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011, THE FIBER FORWARD FIRED AND/OR THE FIBER WAS DAMAGED AT THE TIP AT 25,000 JOULES. PER THE CUSTOMER, THE FIBER CAP DETACHED. ALSO, IT WAS REPORTED THAT THE FIBER CAP WAS RETRIEVED. PER THE CUSTOMER, THE FIBER HAD NO AIMING BEAM. 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 026H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other