BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 2872524 · Received December 12, 2012

    Report

    Report Number
    2937094-2012-01277
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 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 THE PATIENT WAS UNDER ANESTHESIA AND THE DEVICE WAS "INSIDE" THE PATIENT WHEN THE BEAM "STARTED FIRING AT THE TIP OF THE FIBER AT 58,322 JOULES." REPORTEDLY, THE BEAM WAS OBSERVED TO BE RED. THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT HPS BPH FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2090 203H

    Patients

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