BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT HPS FIBER OPTIC

    MDR report key: 3023846 · Received March 26, 2013

    Report

    Report Number
    2937094-2013-00362
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 6, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE SURGICAL FIBER DURING A PROSTATE PROCEDURE, THE FIBER OVERHEATED AND BROKE THE TIP (TIP DETACHED); THE TIP WAS REPORTED TO BE RETRIEVED AND THE CASE WAS COMPLETED USING A SECOND FIBER. THERE WAS NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123430 GREENLIGHT HPS FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2090 244H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other