BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC FOCUS

    MDR report key: 3072411 · Received April 16, 2013

    Report

    Report Number
    3072411
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    January 22, 2013
    Report Date
    April 16, 2013
    Manufacturer
    ETHICON ENDO SURGERY
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    HARMONIC FOCUS SCALPEL MALFUNCTIONED DURING SURGERY. HARMONIC MACHINE WAS ACTIVATED BUT DEVICE WAS NOT COAGULATING TISSUE. REPLACED HARMONIC FOCUS SCALPEL. NO HARM TO PATIENT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163995 HARMONIC FOCUS ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO SURGERY * J4CG0U

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR