BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS FIBER OPTIC

    MDR report key: 3113139 · Received May 9, 2013

    Report

    Report Number
    2937094-2013-00569
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    March 29, 2013
    Report Date
    May 1, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) REFERS TO FORWARD-FIRING OF THE SIDE-FIRING SURGICAL FIBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SIDE-FIRING OF FIBER WAS NOTICED TO HAVE COMMENCED FORWARD FIRING AT 53,515 JOULES DURING A PROSTATE PROCEDURE. THE CASE WAS COMPLETED WITH A SECOND FIBER. "OUTCOME OF PATIENT OK, NO HARM TO PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202704 GREENLIGHT HPS FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2090 248H

    Patients

    Seq Age Sex Outcome Treatment
    1