BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 5688998 · Received May 31, 2016

    Report

    Report Number
    2937094-2016-00582
    Event Type
    Malfunction
    Date Received
    May 31, 2016
    Date of Event
    February 5, 2016
    Report Date
    March 30, 2016
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS FOR FIBER (B)(4): THE GLASS CAP IS FRACTURED AT THE UV GLUE ZONE; THE GLASS CAP DISTAL TO LOCATION OF FRACTURE IS DETACHED AND NOT RETURNED; FIBER CORE IS INTACT; THERE IS NO SIGNS OF MELTING AT THE LOCATION OF THE FRACTURE; THE HEAT SHRINK TUBING OPEN WALL IS COMPROMISED, AND EXHIBITS PARTIALLY ERASED BLUE ARROW INDICATOR. BASED ON THE DEVICE ANALYSIS, THE POTENTIAL FOR FORWARD FIRING MAY EXIST. PROBABLE ROOT CAUSE: BASED ON THE DEVICE ANALYSIS, THE PROBABLE ROOT CAUSE OF THE FAILURE IS: HEAT ACCUMULATION. CAP WEAR WAS ACCELERATED DUE TO ANATOMICAL/PROCEDURAL FACTORS (TISSUE CONTACT AND TECHNIQUE) ENCOUNTERED DURING THE PROCEDURE WHICH WOULD LIMIT THE PERFORMANCE OF THE FIBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT 30,138 JOULES, 7:46 MINUTES WHILE USING THE SURGICAL FIBER DURING A PROSTATE PROCEDURE, THE FIBER BROKE / WAS DAMAGED. THE FIBER WAS REPLACED AND THE PROCEDURE COMPLETED USING A SECOND SURGICAL FIBER. THERE WAS "NO INJURY TO PATIENT" REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343680 GREENLIGHT HPS BPH FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2090 503H

    Patients

    Seq Age Sex Outcome Treatment
    1