BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 2901306 · Received January 2, 2013

    Report

    Report Number
    2937094-2013-00005
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    November 21, 2012
    Report Date
    December 5, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, THE FIBER "CAP DETACHED AT 155913 JOULES". A SECOND FIBER WAS USED TO COMPLETE THE CASE. UNKNOWN IF CAP DETACHED INSIDE PT OR IF RETRIEVAL WAS REQUIRED. NO INJURY TO PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270 GREENLIGHT HPS BPH FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2090 229H

    Patients

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