BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 1844128 · Received September 13, 2010

    Report

    Report Number
    2937094-2010-00105
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    March 17, 2010
    Report Date
    April 22, 2010
    Manufacturer
    AMS INNOVATION CENTER-SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FAILURE ANALYSIS REPORT WAS GENERATED BY AN AMERICAN MEDICAL SYSTEMS QUALITY ENGINEER. THE EXAM DISCLOSED THAT THE FIBER CAP HAD FRACTURED AND HAD PARTIALLY BROKEN OFF; THE CAP EITHER BROKE OFF OR THE ENTIRE CAP SLID OFF. THE EXAM ALSO DISCLOSED THAT BURNT GLUE ON BEVEL PORTION WAS GENERALLY EVIDENT AND THAT THE CAP FRACTURE OR BREAKAGE 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 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 ON THE OUTSIDE OF THE CAP. THE FIBER MAY MELT AT THE CAP MOUTH RESULTING IN CAP DETACHMENT. THE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE TISSUE CONTACT AND EMBEDMENT. THE PRODUCT LABELING (PRODUCT INSERT (B)(4)) WARNS THAT TISSUE CONTACT OR TISSUE PROBING MAY CAUSE FIBER DAMAGE OR BREAKAGE. THE CAP WAS RETRIEVED FROM THE PT AND NO PT INJURY OCCURRED. THE PRODUCT ALSO WARNS OF POSSIBLE CAP DETACHMENT IN THE PATIENT AND INSTRUCTIONS FOR RETRIEVING.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2010 THE FIBER CAP HAD DETACHED AT 15,849 JOULES. THE CAP WAS SUBSEQUENTLY RETRIEVED AND NO PT INJURY OCCURRED. AN EXAM, CONDUCTED BY AN AMERICAN MEDICAL SYSTEMS QUALITY ENGINEER, CONFIRMED THAT THE CAP HAD FRACTURED AND HAD PARTIALLY BROKEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT ADDSTAT SURGICAL FIBER GEX AMS INNOVATION CENTER-SILICON VALLEY NA 940U

    Patients

    Seq Age Sex Outcome Treatment
    1 Other