BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 3851617 · Received June 5, 2014

    Report

    Report Number
    2937094-2014-00441
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FAILURE MODE WAS VERIFIED AND DETERMINED TO BE THE RESULT OF A FAULTY DISPLAY/TOP COVER. THE TOP COVER WAS REPLACED BY THE CUSTOMER, SYSTEM SELF-CHECKS PERFORMED AND ISSUE VERIFIED TO BE RESOLVED.

    Additional Manufacturer Narrative · 1

    SERVICE IN THE FIELD WAS PERFORMED ON (B)(6) 2014. THE TOP COVER THAT WAS REPLACED WAS RETURNED TO AMS ON JULY 29, 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN BEGINNING A PROSTATE PROCEDURE, THE LASER SYSTEM DISPLAYED ERROR CODES 509, 235 AND 302.13 WHEN TURNED ON AND THE PROCEDURE WAS CANCELED. THE PATIENT HAD BEEN ADMINISTERED ANESTHESIA, HOWEVER, THE OUTCOME WAS REPORTED AS "OK"; NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329390 GREENLIGHT XPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-0210

    Patients

    Seq Age Sex Outcome Treatment
    1