BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS BPH FIBER OPTIC

    MDR report key: 3162497 · Received June 6, 2013

    Report

    Report Number
    2937094-2013-00656
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 16, 2012
    Report Date
    May 17, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K120870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    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 WA REPORTED THAT WHILE USING THE SIDE-FIRING SURGICAL FIBER DURING A PROSTATE PROCEDURE, THE FIBER WAS OBSERVED TO BE FORWARD-FIRING AT 52,694 JOULES OF USE. THE CASE WAS COMPLETED USING A SECOND FIBER. THERE WAS NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251604 GREENLIGHT HPS BPH FIBER OPTIC POWRED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2400 233A

    Patients

    Seq Age Sex Outcome Treatment
    1