BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 2227545 · Received August 15, 2011

    Report

    Report Number
    2937094-2011-01706
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K092735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THEY WANTED TO HAVE THE LASER SYSTEM LOOKED AT AND TO MAKE SURE IT WAS WORKING UP TO THE SPECIFICATIONS. AMERICAN MEDICAL SYSTEMS CONTACTED THE CUSTOMER TO FOLLOW UP ON THE REPAIR OF THE LASER SYSTEM. PER THE CUSTOMER, THE LASER SYSTEM WAS WORKING FINE WITH NO FURTHER ISSUES AND HE HAD NOT SINCE RECEIVED THE ERROR MESSAGE CODE 102.9 SINCE HIS INITIAL REPORT. AN AMERICAN MEDICAL SYSTEMS REPRESENTATIVE CONFIRMED WITH AMERICAN MEDICAL SYSTEMS TECHNICAL SUPPORT THAT NO REPAIR WAS NEEDED AT THIS TIME. PER AMERICAN MEDICAL SYSTEMS TECHNICAL SUPPORT, THE EVENT SOUNDED LIKE A SOFTWARE GLITCH. AN AMERICAN MEDICAL SYSTEMS REPRESENTATIVE INFORMED THE CUSTOMER THAT IF THE ERROR MESSAGE CODE 102.9 OCCURRED AGAIN TO CONTACT AMERICAN MEDICAL SYSTEMS WITH DETAILS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011, HE CONTACTED HIS SALES REPRESENTATIVE REGARDING ERROR MESSAGE CODE 1002.9 THAT THEY RECEIVED DURING THE MIDDLE OF A PROCEDURE. PER THE CUSTOMER, THE SALES REPRESENTATIVE SPOKE WITH SOMEONE FROM TECHNICAL SUPPORT. THE CUSTOMER STATED THEY RECEIVED ERROR MESSAGE CODE 102.9 TWICE DURING THE PROCEDURE. PER THE CUSTOMER, THE ERROR MESSAGE CODE 102.9 WAS ABLE TO BE CLEARED AND COMPLETE THE PROCEDURE WITH NO FURTHER ISSUES. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT XPS LASER SYSTEM LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY 0010-0210 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other