BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC

    MDR report key: 22187849 · Received June 11, 2025

    Report

    Report Number
    MW5171343
    Event Type
    Injury
    Date Received
    June 11, 2025
    Date of Event
    May 29, 2025
    Report Date
    June 2, 2025
    Manufacturer
    ETHICON / ETHICON ENDO-SURGERY, LLC
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE RUBBER TIP STARTED TO FRAY WHILE IN USE AND WAS NOT CREATING A PROPER SEAL DURING LAPAROSCOPIC CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814883 HARMONIC INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON / ETHICON ENDO-SURGERY, LLC HAR1120 A9766X

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention