BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC FOCUS

    MDR report key: 2771489 · Received September 10, 2012

    Report

    Report Number
    2771489
    Event Type
    Malfunction
    Date Received
    September 10, 2012
    Date of Event
    August 24, 2012
    Report Date
    September 10, 2012
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT STOPPED FUNCTIONING DURING USE. NEW HANDPIECE OBTAINED AND SURGERY CONTINUED. ON SITE REP NOTIFIED ON DATE OF EVENT.======================MANUFACTURER RESPONSE FOR CURVED SHEARS, TORQUE WRENCH, HARMONIC FOCUS (PER SITE REPORTER).======================REP AWARE ON DATE OF EVENT. NO RESPONSE OFFICIALLY TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC FOCUS INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY * J4AWOX

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR