BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE ADAPTIVE TISSUE TECHNOLOGY

    MDR report key: 4243759 · Received November 11, 2014

    Report

    Report Number
    3005075853-2014-07828
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 30, 2014
    Report Date
    October 30, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. NO DEVICE RECEIVED FOR ANALYSIS AT TIME OF SUBMISSION OF 3500A. DEVICE EVALUATION - NO DEVICE RECEIVED FOR ANALYSIS AT TIME OF SUBMISSION OF 3500A. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HYSTERECTOMY PROCEDURE, THE TEFLON PAD CAME COMPLETELY OFF OF THE CLAMP ARM AND FELL INTO THE PATIENT. THE PAD WAS FOUND AND REMOVED FROM THE PATIENT WITH NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726893 HARMONIC ACE ADAPTIVE TISSUE TECHNOLOGY INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. NA L91N9K

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE