BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 3070149 · Received April 15, 2013

    Report

    Report Number
    2937094-2013-00448
    Event Type
    Malfunction
    Date Received
    April 15, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE BEGINNING OF A PROSTATE PROCEDURE, FIBER BREAKAGE INSIDE OF THE PATIENT NEAR THE TIP WAS NOTED AT 189,075 JOULES. THERE WAS NO INDICATION OR REPORT OF ANY PART OF THE DEVICE REMAINING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER. NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160621 GREENLIGHT HPS BPH FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2090 303H

    Patients

    Seq Age Sex Outcome Treatment
    1