BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 4100970 · Received September 19, 2014

    Report

    Report Number
    2937094-2014-00851
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    February 1, 2013
    Report Date
    August 26, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATION: FAILURE ANALYSIS FOR FIBER (B)(4): THE DISTAL PART OF THE GLASS CAP IS DETACHED AND NOT RETURNED; THE FIBER IS FRACTURED DISTAL TO GLUE ZONE AT THE BEVEL EDGE; THE FIBER IS BLACKENED ALONG 5 CM OF THE DISTAL END; THE HEAT SHRINK TUBE IS MELTED ALONG 5 CM OF THE DISTAL END. BASED ON THE ANALYSIS RESULTS, THE POTENTIAL FOR FORWARD FIRING MAY EXIST. PROBABLE ROOT CAUSE: BASED ON THE PRODUCT ANALYSIS RESULTS, 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, @56,155 JOULES OF USE; 45:09 MINUTES, THE FIBER TIP BURNED OUT. THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER. "NO PATIENT INJURY" REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583882 GREENLIGHT HPS BPH FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-2090 242H

    Patients

    Seq Age Sex Outcome Treatment
    1