BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT HPS FIBER OPTIC

    MDR report key: 2842152 · Received November 13, 2012

    Report

    Report Number
    2937094-2012-01193
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 23, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIBER CAP DETACHED INSIDE THE PT AT 145,338 JOULES DURING A PROSTATE PROCEDURE. IT WAS ALSO REPORTED THAT THE CAP WAS FLUSHED OUT AND WENT DOWN THE DRAIN. THERE WAS NO INDICATION OR REPORT OF ANY PART OF THE DEVICE REMAINING INSIDE THE PT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT HPS FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2090 226H

    Patients

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