BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 3201356 · Received June 26, 2013

    Report

    Report Number
    2937094-2013-00710
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 4, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE MFR REPORT #: 2937094-2013-00357. FIBER ANALYSIS: THE FIBERS GLASS CAP WAS FOUND TO BE DETACHED AND FRACTURED DISTAL TO THE GLUE ZONE; THE FIBER FRACTURED NEAR THE BEVELED EDGE. THE FIBER CAP WAS RETURNED BY THE CUSTOMER. THERE WAS NO INDICATION OR REPORT OF ANY PART OF THE DEVICE REMAINING INSIDE THE PATIENT. THE FIBER CONDITION COULD RESULT IN A FORWARD FIRING CONDITION OF THE SIDE-FIRING SURGICAL FIBER. THE MOST PROBABLE ROOT CAUSE OF THE DEVICE ISSUE WAS DETERMINED TO BE LOCALIZED HEAT ACCUMULATION/USER HANDLING, DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE THE SIDE-FIRING FIBER WAS DAMAGED AT THE TIP AT 135,854 JOULES. A SECOND FIBER WAS USED AND REPORTED TO HAVE COMMENCED FORWARD FIRING AT 42,576 JOULES. THE PROCEDURE WAS COMPLETED WITH A THIRD FIBER. "NO HARM TO PT'S REPORTED. THIS REPORT IS FOR THE FIRST FIBER USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289451 GREENLIGHT HPS BPH FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2090 204H

    Patients

    Seq Age Sex Outcome Treatment
    1