BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 1843971 · Received September 13, 2010

    Report

    Report Number
    2937094-2010-00149
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    May 13, 2010
    Report Date
    June 1, 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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FAILURE ANALYSIS REPORT WAS GENERATED BY AN AMERICAN MEDICAL SYSTEM QUALITY ENGINEER. THE EXAMINATION DISCLOSED THAT THE FIBER BROKE, 2 1/2 INCHES JUST FORWARD OF THE CONTROL KNOB, AT 88,309 JOULES AND THE FIBER WAS CRUSHED AND NOT BURNT. EXCESSIVE BENDING CAUSED THIS FAILURE MECHANISM. THE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE DUE TO EXCESSIVE BENDING. NO PT INJURY WAS REPORTED. THE PRODUCT LABELING (B)(4) WARNS THAT BENDING AT SHARP ANGLES MAY CAUSE FIBER DAMAGE OR BREAKAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2010, THERE WAS FORWARD FIRING AND/OR FIBER DAMAGE AT THE TIP AND FIBER BREAKAGE AT 88,309 JOULES. NO PT INJURY WAS REPORTED. AN EXAMINATION, CONDUCTED BY AN AMERICAN MEDICAL SYSTEM QUALITY ENGINEER, CONFIRMED THAT THE FIBER HAD BROKEN.

    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 007H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other