BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 5170621 · Received October 23, 2015

    Report

    Report Number
    2937094-2015-01046
    Event Type
    Malfunction
    Date Received
    October 23, 2015
    Date of Event
    August 7, 2014
    Report Date
    July 1, 2015
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS FOR FIBER 10-2090-403H-(B)(4): THE FIBER CAP SHOW MILD USAGE; THE GLASS CAP EXHIBITS MILD CHARRED DETRITUS ADHESION AND MILD DEVITRIFICATION AT THE OUTPUT AREA; THE FIBER IS BROKEN AND DETACHED 1 INCH FORWARD OF THE CONTROL KNOB, BETWEEN CONTROL KNOB AND DISTAL TIP; THE SHRINK TUBING/FIBER EXHIBITS SIGNS OF MELTING AT THE BREAK. FIBER CARD ANALYSIS: USE DATE:8/7/2014 -169,440 JOULES. PROBABLE ROOT CAUSE: BASED ON THE DEVICE ANALYSIS, THE PROBABLE ROOT CAUSE OF THE FAILURE IS: EXCESSIVE BENDING/USE HANDLING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, A MEDICAL DEVICE / SURGICAL FIBER MALFUNCTIONED. THE PROCEDURE WAS COMPLETED USING A SECOND SURGICAL FIBER. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701885 GREENLIGHT HPS BPH FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2090 403H

    Patients

    Seq Age Sex Outcome Treatment
    1