BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC FOCUS

    MDR report key: 2974261 · Received February 21, 2013

    Report

    Report Number
    2974261
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 28, 2013
    Manufacturer
    ETHICON ENDO-SURGERY LLC
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RECEIVED A CALL FROM OPERATING ROOM. A PT WAS HAVING A THYROID SURGERY AND WHEN THE SURGEON WOULD USE A HARMONIC FOCUS FROM ETHICON IT WOULD LEAVE WHAT LOOKED LIKE A BLUE FILM OR PIECE OF PLASTIC ON THE TISSUE. IT WAS REPORTED THAT THE SURGEON THOUGHT THEY WERE ABLE TO REMOVE THE BLUE MATTER. PIECE OF BLUE MATTER SAVED FOR RISK AND IS THE SIZE OF A PEN HEAD. THE FOCUS WAS ALSO SEQUESTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76829 HARMONIC FOCUS HARMONIC FOCUS LFL ETHICON ENDO-SURGERY LLC J4CP6K

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR