BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 2960956 · Received February 11, 2013

    Report

    Report Number
    2937094-2013-00194
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 17, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTRATE PROCEDURE, A "FIBER CARD NOT WORKING" MESSAGE WAS RECEIVED WITH TWO ATTEMPTS TO USE THE DEVICE. DURING THE FIRST ATTEMPT, "THE FIBER WAS COUPLED INTO THE MACHINE, FIBER CARD INSERTED, CARD NOT READABLE MESSAGE." FOR THE SECOND ATTEMPT, "THE (FIRST) FIBER CARD WAS EXTRACTED AND REINSERTED AGAIN UNTIL THE 'CLICK' WAS HEARD, SAME FAULT MESSAGE ON THE SCREEN." THE PHYSICIAN PERFORMED A TURP TO COMPLETE THE CASE. REPORTEDLY, "NO DAMAGE TO THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59386 GREENLIGHT HPS BPH FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2090 216H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ACCESSORIES| GREENLIGHT XPS SURGICAL LASER SYSTEM