BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 3042843 · Received April 4, 2013

    Report

    Report Number
    2937094-2013-00424
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 20, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FIBER AND CAP REFER TO THERMAL PROBLEM. FIBER ANALYSIS: THE FIBER TIP WAS FOUND TO BE BROKEN AND MELTED; THE GLASS CAP WAS FOUND TO BE BROKEN DISTAL TO THE FIBER/CAP GLUE ZONE. THERE WAS NO INDICATION OR REPORT OF ANY PART OF THE DEVICE REMAINING INSIDE THE PT. THE FIBER CONDITION COULD RESULT IN A FORWARD FIRING CONDITION OF THE SIDE-FIRING SURGICAL FIBER. THE MOST PROBABLE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE HEAT ACCUMULATION, LIKELY DUE TO TISSUE CONTACT AND/OR ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, THE FIBER CAP DETACHED. NO ADDITIONAL INFORMATION REGARDING THIS CASE IS AVAILABLE. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138371 GREENLIGHT HPS BPH FIBER OPTIC POWERED SURGICAL LASER TREATMENT GEX AMERICAN MEDICAL SYSTEMS 10-2090 203H

    Patients

    Seq Age Sex Outcome Treatment
    1