BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED LASER SURGICAL SYSTEMS

    MDR report key: 2773444 · Received September 28, 2012

    Report

    Report Number
    2937094-2012-01023
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    August 28, 2012
    Report Date
    August 28, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO THE START OF A PROCEDURE, THE LASER SYSTEM MALFUNCTIONED SUCH THAT THE LASER SYSTEM COULD NOT BE UTILIZED TO PERFORM THE INTENDED PROCEDURE. IT IS UNKNOWN IF THE CASE WAS CANCELED. THERE WAS NO REPORT OF A PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED LASER SURGICAL SYSTEMS LASER SYSTEM GEX AMERICAN MEDICAL SYSTEMS 0010-0070 NA

    Patients

    Seq Age Sex Outcome Treatment
    1