BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 3032787 · Received March 29, 2013

    Report

    Report Number
    2937094-2013-00378
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    November 23, 2012
    Report Date
    December 13, 2012
    Manufacturer
    AMS INNOVATIVE CENTER-SAN JOSE
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPONENT CODES FOR FIBER AND CAP REFER TO THE RESULTS CODE FOR THERMAL PROBLEM. FIBER ANALYSIS: THE FIBERS GLASS CAP WAS FOUND TO BE DETACHED; THE FIBER BROKEN PROXIMAL TO THE FIBER/CAP GLUE ZONE. THE FIBER CAP WAS NOT RETURNED BY THE CUSTOMER. THERE WAS NO INDICATION OR REPORT OF ANY PART OF THE DEVICE REMAINING INSIDE THE PATIENT. THE FIBER/ CAP CONDITIONS WOULD RESULT IN A FORWARD FIRING CONDITION OF THE SIDE-FIRING SURGICAL FIBER. THE MOST PROBABLE ROOT CAUSE OF THE DEVICE FAILURE THAT CONTRIBUTED TO THIS FAILURE WAS SUSPECTED TO BE RELATED TO HEAT ACCUMULATION DUE TO ANATOMICAL/ PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE. CAP WEAR WAS ACCELERATED 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, DAMAGE TO THE FIBER TIP WAS OBSERVED (TIP WAS REPORTED TO BE BLACK) AT 233,000 JOULES OF USE. THE METHOD USED TO COMPLETE THE CASE WAS NOT REPORTED. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130714 GREENLIGHT HPS BPH FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMS INNOVATIVE CENTER-SAN JOSE 10-2090 220H

    Patients

    Seq Age Sex Outcome Treatment
    1