BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 1843947 · Received September 13, 2010

    Report

    Report Number
    2937094-2010-00124
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    May 4, 2010
    Report Date
    May 7, 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
    NC, 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 DETACHED. THE EXAMINATION ALSO DISCLOSED THAT THE CAP REGION WAS BURNT AND/OR MELTED BUT THAT THE CAP REMAINED ATTACHED AND INTACT. THE SHRINK TUBE AND OR FIBER JACKET MAY HAVE BEEN MELTED AND/OR BURNT. THE QUALITY ENGINEER ALSO STATED THAT THE CAP GENERALLY EXHIBITED SOME/ALL OF CHAR, DEVITRIFICATION, CRATER, AND MELTED GLASS. 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 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 HEAT ACCUMULATION OF THE FIBER. THE CAP WAS RETRIEVED AND NO PATIENT INJURY OCCURRED. THE PRODUCT LABELING (PRODUCT INSERT 0127-1410) PROVIDES WARNING 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 19,642 JOULES. THE CUSTOMER STATED THAT THE SUDDEN DEGRADATION COULD NOT BE EXPLAINED BUT THAT HE/SHE BELIEVED HE/SHE BROKE THE FIBER WHILE CHANGING TO THE SECOND FIBER. THE CAP WAS SUBSEQUENTLY RETRIEVED AND NO PATIENT INJURY OCCURRED. AN EXAMINATION, CONDUCTED BY AN AMERICAN MEDICAL SYSTEMS QUALITY ENGINEER, DISCLOSED THAT THE CAP REGION WAS BURNT OR MELTED AND THAT THE CAP WAS ATTACHED AND INTACT.

    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 001N

    Patients

    Seq Age Sex Outcome Treatment
    1 Other