BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 6094807 · Received November 10, 2016

    Report

    Report Number
    2937094-2016-01090
    Event Type
    Injury
    Date Received
    November 10, 2016
    Date of Event
    September 28, 2016
    Report Date
    October 24, 2016
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE START OF A BPH SURGICAL PROCEDURE "FIBER CONNECTION ERROR" WAS OBSERVED. THE DEVICE COULD NOT BE USED. THE CASE WAS COMPLETED USING AN ALTERNATE PROCEDURE (TURP). NO HARM TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743271 GREENLIGHT XPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-0210

    Patients

    Seq Age Sex Outcome Treatment
    1 Other