BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 3023826 · Received March 26, 2013

    Report

    Report Number
    2937094-2013-00358
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, THE FIBER TIP DETACHED INSIDE THE PT AND WAS RETRIEVED. A SECOND FIBER WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED "NO INJURY TO THE PT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124507 GREENLIGHT HPS BPH FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2090 302H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other