BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC

    MDR report key: 20063520 · Received August 26, 2024

    Report

    Report Number
    20063520
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    July 26, 2024
    Report Date
    July 26, 2024
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PER DOCTOR, DEVICE DEFECTIVE, STOPPED WORKING DURING CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245793 HARMONIC INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC HAR1136 Y7022C

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female