BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSTAT, SINGLE FIBER (AURA/ORION)

    MDR report key: 2844289 · Received November 8, 2012

    Report

    Report Number
    2937094-2012-01221
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 10, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K924644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PHYSICIAN WAS READY TO USE THE LASER TO PERFORM A LEFT MIDDLE EAR EXPLORATION, OSSICULOPLASTY WITH KTP LASER. THE LASER FIRED AND THERE WAS NO BEAM. THE PHYSICIAN TRIED AGAIN AND SAW THE RED BEAM IN THE FIBER APPROXIMATELY 2 FEET FROM THE ACTUAL MACHINE, 2 WATTS, 0.1 DURATION. THE MACHINE WAS ABOUT 3 FEET FROM THE FIELD. THERE WAS A BREAK IN THE FIBER. THE PROCEDURE WAS COMPLETED "AS PLANNED" WITH A SECOND FIBER. NO PATIENT OR END USER INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUSTAT, SINGLE FIBER (AURA/ORION) POWERED LASER SURGICAL SYSTEMS GEX AMERICAN MEDICAL SYSTEMS 0010-6110 210

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESSORIES| SURGICAL LASER SYSTEM