BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACE

    MDR report key: 1770081 · Received July 15, 2010

    Report

    Report Number
    1770081
    Event Type
    Malfunction
    Date Received
    July 15, 2010
    Date of Event
    June 15, 2010
    Report Date
    July 15, 2010
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE HARMONIC SCALPEL, THE SURGEON NOTICED A BURNING SMELL. WHILE USING THE DEVICE, THE SURGEON NOTED THE BLUE PLASTIC TIP WAS DYING THE PATIENT'S SKIN BLUE. THE AFFECTED AREA WAS A PINPOINT AREA INTERNALLY AND DID NOT IMPACT PATIENT SAFETY DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACE ULTRASONIC DEVICE LFL ETHICON ENDO-SURGERY ACE36E 1095089

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR