BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 2030408 · Received March 9, 2011

    Report

    Report Number
    2937094-2011-00360
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    September 7, 2010
    Report Date
    September 9, 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
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT DESCRIPTION THE CUSTOMER REPORTED TO AMS DID NOT INDICATE A POTENTIAL PT SAFETY ISSUE. THE DEVICE WAS SUBSEQUENTLY RETURNED TO AMS AND ANALYZED. THE INFO FROM THIS FAILURE ANALYSIS WAS REC'D 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 FRACTURED AND PARTIALLY BROKE OFF. THE FIBER INCLUDED A BROKEN OR MELTED BEVELED AREA. THE ENTIRE FIBER CAP SLID OFF. INSUFFICIENT GLUE ON THE BEVEL PORTION OF THE FIBER WAS GENERALLY EVIDENT. THIS DEVICE FAILURE IS ASSOCIATED WITH A MFG DEFECT. THE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE TISSUE CONTACT AND EMBEDMENT. 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 A CUSTOMER ON (B)(6) 2010, THERE WAS DIMINISHED VAPORIZATION; THERE WAS A DECREASE IN FIBER VAPORIZATION EFFICIENCY AT 14,228 JOULES. A FAILURE ANALYSIS, CONDUCTED BY AN AMERICAN MED SYSTEMS QUALITY ENGINEER, DISCLOSED THAT THE FIBER TIP FRACTURED AND PARTIALLY BROKE 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 020H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other