BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AURA XP LASER SYSTEM

    MDR report key: 2222905 · Received August 10, 2011

    Report

    Report Number
    2937094-2011-01622
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    AMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K092735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011 DURING THE MIDDLE OF THE PROCEDURE THE PHYSICIAN RECEIVED A DEVICE PORT OVERHEAT ERROR. AS CONFIRMED WITH AMERICAN MEDICAL SYSTEMS TECHNICAL SUPPORT, THE PHYSICIAN WAS ADVISED TO USE A NEW FIBER. THE PHYSICIAN USED A NEW FIBER AND THE DEVICE PORT OVERHEAT ERROR DID NOT APPEAR WHILE ON THE LINE WITH AMERICAN MEDICAL SYSTEMS TECHNICAL SUPPORT. THE PHYSICIAN CONTINUED WITH THE PROCEDURE. DURING THE PROCEDURE THE NEW FIBER HAD A DEVICE PORT OVERHEAT ERROR WHILE STILL IN THE MIDDLE OF THE PROCEDURE. THE PHYSICIAN RESET THE LASER SYSTEM UNIT AND WAS ABLE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AURA XP LASER SYSTEM LASER SURGICAL INSTRUMENT GEX AMS, INNOVATION CENTER - SILICON VALLEY 0010-8118 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other