BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AURA XP LASER SYSTEM

    MDR report key: 3840823 · Received May 30, 2014

    Report

    Report Number
    2937094-2014-00422
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYSTEM ANALYSIS/SERVICE REPAIR ON MAY 27, 2014: THE REPORTED ¿ERROR CODE 61" ISSUE WAS VERIFIED AND DETERMINED TO BE A FAULTY EYE SAFETY FILTER CABLE. THE EYE SAFETY FILTER CABLE WAS REPLACED. THE SYSTEM WAS TESTED AND VERIFIED THAT THE LASER MEETS MANUFACTURER¿S SPECIFICATIONS. THE EYE SAFETY FILTER CABLE WAS NOT RETURNED TO AMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE ERROR 61 OCCURRED. THE CUSTOMER WAS UNABLE TO CLEAR THE ERROR THAT OCCURRED AND THE CASE WAS CANCELED. THERE WAS NO REPORT OF A PATIENT INJURY; HOWEVER THE MANUFACTURER IS FILING THIS AS DEVICE MALFUNCTION FOR NON-COMPLETION OF CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318268 AURA XP LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-8118

    Patients

    Seq Age Sex Outcome Treatment
    1