BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 4003142 · Received August 12, 2014

    Report

    Report Number
    2937094-2014-00710
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 24, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS FOR FIBER (B)(4): THE FIBER CAP REMAINS ATTACHED AND EXHIBITS A DRILLED THROUGH CONDITION; THE BEVEL SECTION DOES NOT APPEAR MELTED; THE GLASS CAP EXHIBITS MODERATE DETRITUS ADHESION. BASED ON THE ANALYSIS, THE POTENTIAL FOR FORWARD FIRING MAY EXIST. PROBABLE ROOT CAUSE: BASED ON THE PRODUCT ANALYSIS RESULTS, THE PRODUCT COMPLAINT OF "BLOWN FIBER TIP" COLD NOT BE CONFIRMED; A CAP MELTED WAS OBSERVED; 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 DURING A PROSTATE PROCEDURE, FOUR SURGICAL FIBERS WERE DAMAGED AT THE TIP AND NEEDED TO BE REPLACED (AT 1672, 2447, 1041 AND 4157 JOULES OF USE RESPECTIVELY). THE PROCEDURE WAS COMPLETED USING A FIFTH SURGICAL FIBER. THERE WAS NO PATIENT INJURY REPORTED. THIS REPORT IS FOR THE FOURTH FIBER USED. GLAND VOLUME: 25 ML. 1ST FAILED FIBER: TIME EXPENDED: 28 SECONDS. 2ND FAILED FIBER: TIME EXPENDED: 1:30 MINUTES. 3RD FAILED FIBER: TIME EXPENDED: 18 SECONDS. 4TH FAILED FIBER: TIME EXPENDED: 1:11 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478770 GREENLIGHT HPS BPH FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2090 347H

    Patients

    Seq Age Sex Outcome Treatment
    1