BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 1844231 · Received September 13, 2010

    Report

    Report Number
    2937094-2010-00215
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    January 25, 2010
    Report Date
    January 25, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FAILURE ANALYSIS REPORT WAS GENERATED BY AN AMERICAN MEDICAL SYSTEMS QUALITY ENGINEER. THE EXAMINATION DISCLOSED THAT CAP FRACTURED OR HAD PARTIALLY BROKEN OFF AND THAT THE FIBER MAY HAVE INCLUDED A BROKEN OR MELTED BEVEL AREA. THE EXAMINATION ALSO DISCLOSED THAT BURNT GLUE ON THE BEVEL PORTION OF THE FIBER WAS GENERALLY EVIDENT. THE DEVICE FAILURE WAS ASSOCIATED WITH A LACK OF COOLING. THE 2090 FIBER ENDURES A HIGHER POWER, HAS A REFLECTIVE CAP AREA, AND MAY BE SUBJECTED TO MORE HEAT, ESPECIALLY IF COOLING IS BLOCKED BY TISSUE CONTACT. TISSUE CONTACT CREATES CHAR WHICH FURTHER INSULATES THE CAP FROM COOLING AND INCREASES HEAT BY ABSORBING ENERGY. THE HEAT CONTRIBUTES TO DEVITRIFICATION AND ASSOCIATED WEAKENING OF THE GLASS, MAKING IT SUBJECT TO BREAKAGE FROM MELTING OR MECHANICAL OR THERMAL STRESS. GLUE BURNING INCREASES PRESSURE IN THE CAP. ENERGY REFLECTED BACK AT THE FIBER CAP FROM A SCOPE, SEED, STONE OR OTHERWISE MAY HAVE CONTRIBUTED TO AND/OR CREATED ANY MELTING IN THE CRATER AREA OF THE FIBER CAP. THE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE TISSUE CONTACT AND EMBEDMENT. NO PT INJURY WAS REPORTED. 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 PT AND INSTRUCTIONS FOR RETRIEVING.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2010, THE AIMING BEAM FIRED STRAIGHT OUT OF THE FIBER AT 45,974 JOULES. NO PT INJURY WAS REPORTED. AN EXAMINATION, CONDUCTED BY AN AMERICAN MEDICAL SYSTEMS QUALITY ENGINEER, DISCLOSED THAT THE CAP HAD FRACTURED OR PARTIALLY BROKEN OFF.

    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 940Z

    Patients

    Seq Age Sex Outcome Treatment
    1 Other