BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS FIBER OPTIC

    MDR report key: 2936838 · Received January 15, 2013

    Report

    Report Number
    2937094-2013-00086
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    October 18, 2012
    Report Date
    October 24, 2012
    Manufacturer
    AMS INNOVATIVE CENTER-SAN JOSE
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FAILURE ANALYSIS DISCLOSED THAT THE FIBER CAP WAS FOUND TO BE INTACT AND ATTACHED, HOWEVER SHOWED A DRILLED THROUGH CONDITION. THE FIBER CAP WAS ALSO FOUND TO EXHIBIT DETRITUS, CHAR, DEVITRIFICATION AND MELTED GLASS. THE FIBER CAP CONDITION WOULD PREVENT PROPER FIBER FUNCTION; LIKELY RESULTING IN A DIFFUSE BEAM AND REDUCED TISSUE VAPORIZATION EFFICIENCY. DRILLED THROUGH CAP CONDITION MAY ALSO RESULT IN A FORWARD FIRING CONDITION OF THE SIDE-FIRING SURGICAL FIBER. THE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE HEAT ACCUMULATION DUE TO TISSUE CONTACT AND OR TECHNIQUE AND ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, LIMITING THE PERFORMANCE OF THE FIBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, THERE WAS DIMINISHED TISSUE VAPORIZATION. THE PROCEDURE WAS COMPLETED WITH A THIRD FIBER. THERE WAS NO REPORT OF PATIENT INJURY. THIS REPORT IS FOR THE SECOND FIBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22592 GREENLIGHT HPS FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMS INNOVATIVE CENTER-SAN JOSE 0010-2090 041H

    Patients

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