BEUDAMED
    FDA Adverse Event Other Summary report: N

    INDIGO OPTIMA LASER SYSTEM

    MDR report key: 717706 · Received November 17, 2005

    Report

    Report Number
    1527736-2005-05592
    Event Type
    Other
    Date Received
    November 17, 2005
    Date of Event
    September 9, 2005
    Report Date
    November 16, 2005
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI0
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    426870-0 DATE SENT: 11/21/2005 H1: DECISION CHANGED TO NO REPORTABLE. H2: INFORMATION IN FILE DOCUMENTED THAT THE EVENT WAS COMPLETED AND THERE WERE NO PATIENT OUTCOMES. A BACK UP DEVICE OF THE SAME NATURE WAS USED TO COMPLETE THE CASE.

    Description of Event or Problem · 1

    IN ATTEMPTING TO BEGIN A CASE THE DISPLAY WAS BLACKED OUT. LASER APPEARED TO BE RUNNING, BUT THERE WAS NO DISPLAY. THE SALES REPS DEMO LASER WAS USED TO COMPLETE THE CASE SUCCESSFULLY WITH NO PATIENT CONSEQUENCE. LASER BEING RETURNED FOR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDIGO OPTIMA LASER SYSTEM LASER GEX ETHICON ENDO-SURGERY, INC. (CINCINNATI0 NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other