BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED DELIVERY DEVICE, GREENLIGHT

    MDR report key: 2577947 · Received May 11, 2012

    Report

    Report Number
    2937094-2012-00488
    Event Type
    Malfunction
    Date Received
    May 11, 2012
    Date of Event
    November 16, 2011
    Report Date
    November 22, 2011
    Manufacturer
    AMS INNOVATIVE CENTER-SAN JOSE
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S INITIAL REPORT OF DIMINISHED FIBER VAPORIZATION IS NOT CONSIDERED A REPORTABLE ISSUE. THE DEVICE WAS RETURNED TO THE MANUFACTURER AND ANALYZED. UPON ANALYSIS OF THE RETURNED FIBER, THE FIBER CAP WAS FOUND TO BE FRACTURED AND PARTIALLY BROKEN OFF, AND SHOWED SIGNS OF BURNING/OVER HEATING. BASED ON THE ANALYSIS FINDINGS, THE FIBER CONDITION WOULD RESULT IN FORWARD FIRING OF THE SIDE FIRING FIBER, WHICH HAS BEEN IDENTIFIED AS A POTENTIAL SAFETY ISSUE. THE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE HEAT ACCUMULATION, LIKELY DUE TO TISSUE CONTACT AND OR AND ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE. THE PRODUCT LABELING WARNS THAT TISSUE CONTACT, TISSUE PROBING AND BENDING FIBER AT SHARP ANGLES MAY CAUSE FIBER DAMAGE OR BREAKAGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SIGNIFICANTLY DIMINISHED FIBER VAPORIZATION AT 45,713 JOULES DURING A PROSTATE PROCEDURE. THE CASE WAS COMPLETED WITH A SECOND FIBER. THE PATIENT OUTCOME WAS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGLED DELIVERY DEVICE, GREENLIGHT SURGICAL FIBER GEX AMS INNOVATIVE CENTER-SAN JOSE 0010-2090 115H

    Patients

    Seq Age Sex Outcome Treatment
    1 GREENLIGHT SURGICAL LASER SYSTEM| & ACCESSORIES