BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AURA XP LASER WITH STARPULSE

    MDR report key: 2831225 · Received November 6, 2012

    Report

    Report Number
    2937094-2012-01173
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 17, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K951034
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE LASER SYSTEM DISPLAYED ERRORS INDICATIVE OF A SYSTEM MALFUNCTION. THE LASER SYSTEM ERRORS WERE UNABLE TO BE CLEARED BY THE USER. THE SYSTEM WAS NO LONGER ABLE TO BE UTILIZED, AND THE PROCEDURE WAS ABORTED. CUSTOMER STATED THE PROCEDURE WOULD BE RESCHEDULED; DATE NOT SPECIFIED. THERE WAS NO REPORT OF A PT INJURY; HOWEVER THE MANUFACTURER IS FILING THIS AS SURGICAL INTERVENTION DUE TO THE PT REQUIRING AN ADDITIONAL PROCEDURE AS A RESULT OF THE INCOMPLETION OF THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AURA XP LASER WITH STARPULSE POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-8118 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SURGICAL FIBER (S)