BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 7028559 · Received November 14, 2017

    Report

    Report Number
    2937094-2017-00994
    Event Type
    Malfunction
    Date Received
    November 14, 2017
    Date of Event
    October 28, 2017
    Report Date
    October 28, 2017
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BPH PROCEDURE, ERRORS 213; 521 AND 302.13 WERE NOTED. REPORTEDLY, WHEN TRIED TO RESTART THE SYSTEM, THE LASER DID NOT TURN ON. THE SURGERY WAS COMPLETED WITH AN ALTERNATIVE PROCEDURE "RTU-MONOPOLAR". PATIENT OUTCOME: "STABLE" REPORTED. NO INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808334 GREENLIGHT XPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-0210

    Patients

    Seq Age Sex Outcome Treatment
    1