BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 3883407 · Received June 19, 2014

    Report

    Report Number
    2937094-2014-00524
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    February 26, 2014
    Report Date
    March 4, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS FOR FIBER (B)(4): THE GLASS CAP WAS DETACHED AND NOT RETURNED; THE FIBER WAS FRACTURED PROXIMAL TO GLUE ZONE; THE FIBER WAS BLACKENED ALONG 3 INCHES FROM THE BREAK POINT; THE HEAT SHRINK TUBE HAS MELTED AND TORN ALONG 3 INCHES FROM THE BREAK POINT. BASED ON THE ANALYSIS, THE POTENTIAL FOR FORWARD FIRING MAY ALSO EXIST. PROBABLE ROOT CAUSE: BASED ON THE PRODUCT ANALYSIS RESULTS, THE PROBABLE ROOT CAUSE OF THE FAILURE IS: HEAT ACCUMULATION DUE TO ANATOMICAL/PROCEDURAL FACTORS (TISSUE CONTACT AND TECHNIQUE) ENCOUNTERED DURING THE PROCEDURE WHICH LIMITING THE PERFORMANCE OF THE FIBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE SURGICAL FIBER DURING A PROSTATE PROCEDURE, THE FIBER CAP MALFUNCTIONED. THE PROCEDURE WAS COMPLETED USING A SECOND SURGICAL FIBER. THERE WAS NO REPORT OF PATIENT INJURY. GLAND VOLUME: 51 ML. TIME EXPENDED: 1:10 MINUTES. JOULES USED: 5469.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361020 GREENLIGHT HPS BPH FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2090 320H

    Patients

    Seq Age Sex Outcome Treatment
    1