BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 3140085 · Received May 29, 2013

    Report

    Report Number
    2937094-2013-00634
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    November 5, 2012
    Report Date
    November 15, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FIBER ANALYSIS: THE FIBER IS BROKEN DISTAL TO GLUE ZONE. THE FIBER CAP IS FRACTURED DISTAL TO GLUE ZONE (CLOSE TO DISTAL END OF THE HEAT SHRINK TUBE). THE BROKEN FIBER TIP LOOKS BLACK. THE FIBER JACKET AND THE HEAT SHRINK TUBE CLOSE TO THE GLASS CAP OPEN END ARE MELTED AND DAMAGED. BASED ON THE ANALYSIS FINDINGS THE FIBER/CAP CONDITIONS WOULD RESULT IN FORWARD FIRING. THE MOST PROBABLE ROOT CAUSE THAT CONTRIBUTED TO THIS FAILURE WAS SUSPECTED TO BE LOCALIZED HEAT ACCUMULATION/USER HANDLING DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE SURGICAL FIBER DURING A PROSTATE PROCEDURE, THE FIBER TIP WAS DAMAGED AT 46,337 JOULES. A SECOND FIBER WAS USED TO COMPLETE THE CASE. PT OUTCOME: UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234762 GREENLIGHT HPS BPH FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2090 221H

    Patients

    Seq Age Sex Outcome Treatment
    1