BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 2030417 · Received March 7, 2011

    Report

    Report Number
    2937094-2011-00324
    Event Type
    Malfunction
    Date Received
    March 7, 2011
    Date of Event
    August 4, 2010
    Report Date
    August 26, 2010
    Manufacturer
    AMS INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO AMS AND ANALYZED. THE INFO FROM THIS FAILURE ANALYSIS WAS RECEIVED ON (B)(6) 2011 AND RESULTS OF THE FAILURE ANALYSIS INDICATED THAT AN MDR WAS REQUIRED. THE FAILURE ANALYSIS DISCLOSED THAT THE FIBER CAP DETACHED. THE FIBER MELTED, PARTED AT THE CAP; THE SHRINK TUBE MELTED; THE JACKET AND SHRINK TUBE WERE BURNT. THIS DEVICE FAILURE IS ASSOCIATED WITH A LACK OF COOLING. THE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE HEAT ACCUMULATION. 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, THE FIBER CAP DETACHED AT 14,530 JOULES. A FAILURE ANALYSIS, CONDUCTED BY AN AMERICAN MEDICAL SYSTEMS QUALITY ENGINEER, DISCLOSED THAT THE FIBER CAP DETACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT ADDSTAT SURGICAL FIBER GEX AMS INNOVATION CENTER - SILICON VALLEY NA 015T

    Patients

    Seq Age Sex Outcome Treatment
    1 Other