BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 2161733 · Received May 17, 2011

    Report

    Report Number
    2937094-2011-01059
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 28, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT DESCRIPTION THE CUSTOMER REPORTED TO AMS DID NOT INDICATE A POTENTIAL PATIENT SAFETY ISSUE. THE DEVICE WAS SUBSEQUENTLY RETURNED TO AMS AND ANALYZED. THE INFORMATION FROM THIS FAILURE ANALYSIS WAS RECEIVED ON (B)(6) 2011 AND THE RESULTS OF THE FAILURE ANALYSIS INDICATED THAT AN MDR WAS REQUIRED. THE FAILURE ANALYSIS DISCLOSED THAT THE FIBER CAP REGION BURNED AND MELTED, THE CAP REMAINED INTACT AND ATTACHED. THE FIBER CAP WAS DRILLED THROUGH. THE FIBER CAP EXHIBITED CHAR, DEVITRIFICATION, CRATER AND MELTED GLASS. THE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE HEAT ACCUMULATION. THE PRODUCT LABELING (PRODUCT INSERT 0127-1410) WARNS THAT TISSUE CONTACT OR TISSUE PROBING MAY CAUSE FIBER DAMAGE OR BREAKAGE. THE PRODUCT LABELING ALSO WARNS OF POSSIBLE CAP DETACHMENT IN THE PATIENT AND INSTRUCTIONS FOR RETRIEVING.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011, THERE WAS SIGNIFICANTLY DIMINISHED FIBER VAPORIZATION EFFICIENCY AT 35,610 JOULES. A FAILURE ANALYSIS, CONDUCTED BY AN AMERICAN MEDICAL SYSTEMS QUALITY ENGINEER, DISCLOSED THAT THE FIBER CAP REGION BURNED AND MELTED, THE CAP REMAINED INTACT AND ATTACHED. THE FIBER CAP WAS DRILLED THROUGH.

    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 035H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other