BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT HPS LASER SYSTEM

    MDR report key: 6795861 · Received August 15, 2017

    Report

    Report Number
    2937094-2017-00731
    Event Type
    Malfunction
    Date Received
    August 15, 2017
    Report Date
    August 3, 2017
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SYSTEM ANALYSIS/SERVICE REPAIR ON AUGUST 09, 2017 THE REPORTED ISSUE WAS CONFIRMED AND THE FAULTY DISPLAY WAS REPLACED. THE SYSTEM WAS TESTED AND VERIFIED TO MEET MANUFACTURER¿S SPECIFICATIONS. THE SUSPECTED FAULTY DISPLAY HAS NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION UPDATED. DEVICE EVALUATED BY MANUFACTURER UPDATED. SERVICE IN THE FIELD WAS PERFORMED ON AUGUST 09, 2017. THE REPLACED LCD WITH CVR HPS WAS RECEIVED AT THE MANUFACTURER ON AUGUST 15, 2017.

    Additional Manufacturer Narrative · 1

    SERVICE IN THE FIELD WAS PERFORMED ON AUGUST 09, 2017. THE REPLACED LCD WITH CVR HPS WAS RECEIVED AT THE MANUFACTURER ON AUGUST 15, 2017. THE LCD WITH CVR HPS WAS DISCARDED WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION OF A PROSTATE PROCEDURE, IT WAS NOTED THAT THE LASER DISPLAY WAS BLANK AS THEY WERE GETTING READY TO START THE CASE. THE LASER WAS REBOOTED HOWEVER THIS DID NOT RESOLVE THE ISSUE. THE PROCEDURE COULD NOT BE COMPLETED AND WAS RESCHEDULED. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574500 GREENLIGHT HPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-0070

    Patients

    Seq Age Sex Outcome Treatment
    1