BEUDAMED
    FDA Adverse Event Other Summary report: N

    INDIGO OPTIMA LASER SYSTEM

    MDR report key: 717699 · Received November 17, 2005

    Report

    Report Number
    1527736-2005-05590
    Event Type
    Other
    Date Received
    November 17, 2005
    Date of Event
    September 20, 2005
    Report Date
    September 20, 2005
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GEX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    426666-0 DATE SENT: 11/21/2005 H1: DECISION CHANGED TO NOT 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

    DURING SET UP FOR THE PROCEDURE, AFTER THE LASER WAS TURNED ON, THE PLUG ON THE BACK OF THE UNIT WHERE THE POWER CORD PLUGS IN SPARKED AND THEN STARTED SMOKING. THE LASER WAS POWERED OFF AND THE CASE WAS STARTED AND FINISHED USING THE REP'S DEMO LASER WITH NO PATIENT CONSEQUENCE. THE LASE IS TO BE SENT IN FOR REPAIR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other