BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 1944061 · Received December 29, 2010

    Report

    Report Number
    2937094-2010-01491
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    September 15, 2010
    Report Date
    December 22, 2010
    Manufacturer
    AMS, 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

    A FAILURE ANALYSIS REPORT WAS GENERATED BY AN AMERICAN MEDICAL SYSTEMS QUALITY ENGINEER. THE EXAMINATION DISCLOSED THAT THE FIBER CAP REGION WAS BURNT AND/OR MELTED BUT THE CAP REMAINED INTACT AND ATTACHED. THE SHRINK TUBE AND/OR FIBER JACKET MAYBE MELTED AND/OR BURNT. ALSO, THE BEVELED SECTION OFTEN MELTED AND EXHIBITED BURNT GLUE. AND THE FIBER CAP GENERALLY EXHIBITED SOME OR ALL OF CHAR, DEVITRIFICATION, CRATER AND MELTED GLASS. THIS IS ASSOCIATED WITH A LACK OF COOLING. THE 2090 FIBER ENDURES A HIGHER POWER AS A RESULT OF 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 HEAT ACCUMULATION OF THE FIBER.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2010, THERE WAS SIGNIFICANTLY DIMINISHED VAPORIZATION EFFICIENCY AT 58,847 JOULES. THIS WAS CONSIDERED A NON-SAFETY RELATED COMPLAINT AND DID NOT REQUIRE AN MDR. HOWEVER, AN EXAMINATION CONDUCTED BY AN AMERICAN MEDICAL SYSTEMS QUALITY ENGINEER ON (B)(6) 2010, CONFIRMED THAT THE FIBER CAP REGION WAS BURNT AND/OR MELTED BUT THE CAP REMAINED INTACT AND ATTACHED. BASED ON RESULTS FROM THIS EXAMINATION, AN MDR IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT ADDSTAT SURGICAL FIBER GEX AMS, INNOVATION CENTER-SILICON VALLEY NA 023H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other