BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 3032786 · Received March 29, 2013

    Report

    Report Number
    2937094-2013-00379
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    AMS INNOVATIVE CENTER-SAN JOSE
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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, THE FIBER TIP WAS DAMAGED. THE CASE WAS COMPLETED USING A SECOND FIBER. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131162 GREENLIGHT HPS BPH FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMS INNOVATIVE CENTER-SAN JOSE 10-2090 219H

    Patients

    Seq Age Sex Outcome Treatment
    1