BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 2092104 · Received April 6, 2011

    Report

    Report Number
    2937094-2011-00567
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    September 9, 2010
    Report Date
    September 22, 2010
    Manufacturer
    AMS INNOVATION CENTER-SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS 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/OR MELTED, THE CAP REMAINED INTACT AND ATTACHED. THE SHRINK TUBE AND/OR FIBER JACKET MELTED AND/OR BURNED. THE BEVELED SECTION MELTED AND EXHIBITED BURNT GLUE. THE FIBER CAP GENERALLY EXHIBITED SOME/ALL OF CHAR, DEVITRIFICATION, CRATER AND MELTED GLASS. THIS DEVICE FAILURE IS ASSOCIATED WITH THE LACK OF COOLING. 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) 2010, THE FIBER FORWARD FIRED AT 21,656 JOULES. PER THE CUSTOMER, THE PROCEDURE WAS COMPLETED WITH THIS FIBER AT 120,120 JOULES. A FAILURE ANALYSIS, CONDUCTED BY AN AMERICAN MEDICAL SYSTEMS QUALITY ENGINEER, DISCLOSED THAT THE FIBER CAP REGION BURNED AND/OR MELTED, THE CAP REMAINED INTACT AND ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT ADDSTAT SURGICAL FIBER GEX AMS INNOVATION CENTER-SILICON VALLEY NA 011H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other