BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT HPS FIBER OPTIC

    MDR report key: 3132958 · Received May 16, 2013

    Report

    Report Number
    2937094-2013-00565
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE FIRST FIBER TIP HAD A "TORN LOOK" BUT NOT DETACHED AT 0 JOULES. THE SECOND FIBER TIP HAD A "TORN LOOK" BUT NOT DETACHED AT 0 JOULES. TURP WAS USED TO COMPLETE THE CASE. "OUTCOME OF PATIENT OK, NO HARM TO PATIENT." WAS REPORTED. THIS REPORT IS FOR THE SECOND FIBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218525 GREENLIGHT HPS FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2090 248H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other