BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 2121877 · Received May 23, 2011

    Report

    Report Number
    2937094-2011-01065
    Event Type
    Malfunction
    Date Received
    May 23, 2011
    Date of Event
    December 9, 2010
    Report Date
    January 4, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO AMS AND ANALYZED. THE INFORMATION FROM THIS FAILURE ANALYSIS WAS RECEIVED ON (B)(6) 2011 AND THE RESULTS OF THE FAILURE ANALYSIS INDICATED THAT AN MDR WAS REQUIRED. THE FAILURE ANALYSIS DISCLOSED THE FIBER TIP WAS DAMAGED FROM OUT OF THE BOX. THE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE A POSSIBLE MANUFACTURING DEFECT OR CUSTOMER HANDLING. THE PRODUCT LABELING (PRODUCT INSERT (B)(4)) WARNS THAT TISSUE CONTACT OR TISSUE PROBING MAY CAUSE FIBER DAMAGE OR BREAKAGE. THE PRODUCT LABELING ALSO WARNS OF POSSIBLE CAP DETACHMENT IN THE PATIENT AND INSTRUCTIONS FOR RETRIEVING.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2010, THE FIBER TIP WAS MISSING WHEN THE FIBER WAS TAKEN OUT FROM THE PACKAGE AT 0 JOULES. A FAILURE ANALYSIS, CONDUCTED BY AN AMERICAN MEDICAL SYSTEMS QUALITY ENGINEER, DISCLOSED THE FIBER TIP WAS DAMAGED FROM OUT OF THE BOX.

    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 029H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other