BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 6327156 · Received February 13, 2017

    Report

    Report Number
    2937094-2017-00121
    Event Type
    Malfunction
    Date Received
    February 13, 2017
    Date of Event
    January 10, 2017
    Report Date
    January 27, 2017
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION THE LASER DISPLAYED ERROR CODE 211, 235 AND 202.1. THE CUSTOMER WAS UNABLE TO RESOLVE THE ISSUE THAT OCCURRED AND THE CASE WAS COMPLETED BY AN ALTERNATIVE PROCEDURE (TURP). PATIENT OUTCOME: THERE WAS NO REPORT OF A PATIENT OR USER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108332 GREENLIGHT XPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-0210

    Patients

    Seq Age Sex Outcome Treatment
    1