BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 9520149 · Received December 26, 2019

    Report

    Report Number
    3005075853-2019-24753
    Event Type
    Injury
    Date Received
    December 26, 2019
    Date of Event
    January 1, 2015
    Report Date
    December 2, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 12/26/2019. DATE OF EVENT: PUBLICATION YEAR OF 2015. MEDICAL DEVICE: BATCH # UNK. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED.

    Description of Event or Problem · 1

    TITLE: EXPERIENCE OF INTRA-OPERATIVE NEUROMONITORING OF RECURRENT LARYNGEAL NERVE DURING THYROIDECTOMY. AUTHOR/S: TENG, C. CITATION: EUR SURG (2015) 47 (SUPPL 1): S192. DOI: 10.1007/S10353-015-0305-0. THE OBJECTIVE OF THIS STUDY WAS TO INVESTIGATE THE BENEFIT OF INTRA-OPERATIVE NEUROMONITORING OF RECURRENT LARYNGEAL NERVE DURING THYROIDECTOMY. RETROSPECTIVELY ANALYZING THE CLINICAL MATERIALS OF 57 PATIENTS WHO HAD THYROIDECTOMY FROM 2012.1 TO 2012. 12, INCLUDING 50 CASES OF THYROID CARCINOMA, FIVE CASES OF GIANT GOITERS, AND TWO CASES OF RECURRENT GOITERS. A HARMONIC SCALPEL (ETHICON) WAS USED DURING THE PROCEDURE. REPORTED COMPLICATIONS INCLUDED THERMAL INJURY OF HARMONIC SCALPEL CAUSING DECREASED R2 SIGNALS (N-3) IN WHICH 3 CASES WERE TREATED IMMEDIATELY, AND TRANSIENT VOCAL PARALYSIS (N-2) WHICH RECOVERED 6 WEEKS LATER. IN CONCLUSION, INTRA- OPERATIVE NEUROMONITORING OF RECURRENT LARYNGEAL NERVE WAS QUITE USEFUL IN FINDING AND CONFIRMING THE NERVE, AND IT ALSO COULD DETECT INJURY OF NERVE DURING OPERATION, WHICH IMPROVED THE SAFETY OF SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1315105 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1