BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 2940963 · Received January 29, 2013

    Report

    Report Number
    2937094-2013-00152
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPONENT CODES FIBER AND CAP REFER TO THE RESULTS CODE THERMAL PROBLEM. FIBER ANALYSIS: THE FIBER CAP WAS DETACHED AND THE FIBER IS BROKEN PROXIMAL TO THE GLUE ZONE. THE FIBER CAP WAS NOT RETURNED WITH THE PRODUCT. UNABLE TO CONFIRM ANY EVIDENCE OF BURNED AND CHARRED HEAT SHRINK OR GLUE RESIDUE DUE TO THE MISSING CAP. THE FIBER/CAP CONDITIONS WOULD RESULT IN FORWARD-FIRING. THE MOST PROBABLE ROOT CAUSE THAT CONTRIBUTED TO THIS FAILURE WAS SUSPECTED TO BE HEAT ACCUMULATION DUE TO TISSUE CONTACT AND OR TECHNIQUE AND ANATOMICAL/PROCEDURE FACTORS ENCOUNTERED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A VISIBLE FLASH, THEN THE FIBER STOPPED FIRING AND THERE WAS NO VAPORIZATION AT 81,909 JOULES INTO THE CASE. A SECOND FIBER WAS USED TO COMPLETE THE PROCEDURE. "NO HARM TO THE PATIENT/USER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39016 GREENLIGHT HPS BPH FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2090 220H

    Patients

    Seq Age Sex Outcome Treatment
    1 GREENLIGHT HPS LASER SYSTEM| ACCESSORIES