BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BP FIBER OPTIC

    MDR report key: 3130063 · Received May 20, 2013

    Report

    Report Number
    2937094-2013-00608
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    January 24, 2013
    Report Date
    April 3, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FIBER ANALYSIS: THE FIBERS GLASS CAP WAS FOUND TO BE DETACHED; THE FIBER BROKEN PROXIMAL TO THE FIBER/CAP GLUE ZONE. THE FIBER CAP WAS RETURNED BY THE CUSTOMER AND WAS FOUND TO SHOW SIGNS OF CHAR AND MELTING. THE FIBER CONDITION COULD RESULT IN A FORWARD FIRING CONDITION OF THE SIDE-FIRING SURGICAL FIBER. THE MOST PROBABLE ROOT CAUSE OF THE DEVICE ISSUE WAS DETERMINED 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 FIBERS TIP WAS DAMAGED AT 75,981 JOULES OF USE. AT 23,607 JOULES OF USE WHILE USING THE SECOND SURGICAL FIBER, THE FIBER BROKE IN HALF WHILE INSIDE THE SCOPE AND WAS RETRIEVED. THE CASE WAS COMPLETED USING A THIRD FIBER. THERE WAS NO INJURY REPORTED. THIS REPORT IS FOR THE FIRST FIBER USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223283 GREENLIGHT HPS BP FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2090 203H

    Patients

    Seq Age Sex Outcome Treatment
    1