BEUDAMED
    FDA Adverse Event No answer provided Summary report: N

    INSTRUMENT, ULTRASONIC SURGICAL

    MDR report key: 16310883 · Received February 7, 2023

    Report

    Report Number
    16310883
    Event Type
    No answer provided
    Date Received
    February 7, 2023
    Date of Event
    December 23, 2022
    Report Date
    January 18, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    LFL
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING SURGERY, THE TIP OF THE DAVINCI HARMONIC SHEAR BROKE IN HALF WHILE BEING USED BY THE SURGEON IN THE PATIENT'S ABDOMEN. WE FOUND THE DETACHED PIECE OF EQUIPMENT AND REMOVED IT FROM THE PT. AN X-RAY WAS PERFORMED TO ENSURE NO PIECES REMAINED AND THE X-RAY WAS CLEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1136264 INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown