BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOCUS

    MDR report key: 1840264 · Received September 17, 2010

    Report

    Report Number
    1840264
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 17, 2010
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    THE HARMONIC FOCUS HANDPIECE WOULD NOT PASS AUTO-TEST. IT WAS REMOVED FROM THE FIELD AND A NEW PRODUCT WAS OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOCUS ULTRASONIC DEVICE LFL ETHICON ENDO-SURGERY FCS9 *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR