BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREELIGHT HPS BPH FIBER OPTIC

    MDR report key: 2864526 · Received December 6, 2012

    Report

    Report Number
    2937094-2012-01255
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 22, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE CODE REFERS TO FORWARD-FIRING OF THE SIDE-FIRING SURGICAL FIBER; A CODE REQUEST HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SIDE-FIRING FIBER WAS NOTICED TO HAVE COMMENCED FORWARD FIRING AT 83,588 JOULES DURING A PROSTATE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER. NO PATIENT OR END USER INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREELIGHT HPS BPH FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2090 016H

    Patients

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