BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 2896659 · Received December 28, 2012

    Report

    Report Number
    2937094-2012-01363
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    June 1, 2012
    Report Date
    September 14, 2012
    Manufacturer
    AMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) REFERS TO FORWARD-FIRING OF THE SIDE-FIRING SURGICAL FIBER. FIBER ANALYSIS: THE FIBER CAP REGION BURNT AND MELTED. THE FIBER CAP REMAINS INTACT AND EXHIBITS A DRILLED THROUGH CONDITION. THE FIBER SHRINK TUBE AND FIBER JACKET ARE SEVERELY MELTED AND BURNT. THE BEVEL SECTION MELTED AND EXHIBITS BURNT GLUE. THE FIBER CAP EXHIBITS DETRITUS, CHAR, DEVITRIFICATION AND MELTED GLASS. THE FIBER CAP CONDITION WOULD RESULT IN REDUCED VAPORIZATION EFFICIENCY. THE POTENTIAL FOR FORWARD FIRING EXISTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, THE FIRST FIBER WAS CHARD AND WOULD NOT FIRE AT 26,000 JOULES. THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMS GREENLIGHT HPS BPH FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMS 0010-2090 103H

    Patients

    Seq Age Sex Outcome Treatment
    1 GREENLIGHT SURGICAL LASER SYSTEM| ACCESSORIES