BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS GREENLIGHT HPS FIBER

    MDR report key: 2865368 · Received October 22, 2012

    Report

    Report Number
    2937094-2012-01118
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    March 21, 2012
    Report Date
    May 13, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER ASSIGNED MODEL NUMBER 0010-2093 IS DESIGNATED FOR (B)(6) DISTRIBUTION. THIS REPORT IS BEING SUBMITTED AS THE MODEL 0010-2093 IS IDENTICAL IN DESIGN AND MANUFACTURE TO THE COMMERCIALLY AVAILABLE MODEL 0010-2090 ANGLED DELIVERY DEVICE, GREENLIGHT (K062719). FIBER ANALYSIS: THE FIBER CAP WAS FOUND TO BE DETACHED; FIBER WAS BROKEN PROXIMAL TO GLUE ZONE. THE FIBER CAP WAS NOT RETURNED BY THE CUSTOMER. THE FIBER/CAP CONDITIONS WOULD RESULT IN FORWARD FIRING. IT WAS REPORTED THAT 150,116 JOULES WERE USED DURING THE CASE. THE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE HEAT ACCUMULATION, LIKELY DUE TO TISSUE CONTACT AND OR AND ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, RESULTING IN CAP DETACHMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AIMING BEAM STOPPED DURING LASER IRRITATION DURING A PROSTATE PROCEDURE. THERE WAS NO REPORT THAT ANY PART OF THE DEVICE REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMS GREENLIGHT HPS FIBER POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2093 148J

    Patients

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