BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 10601730 · Received September 29, 2020

    Report

    Report Number
    3005075853-2020-05022
    Event Type
    Injury
    Date Received
    September 29, 2020
    Report Date
    September 3, 2020
    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 OF EVENT: PUBLICATION YEAR OF 2019. 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    TITLE: SCARLESS NECK ENDOSCOPIC THYROIDECTOMY VIA THE BREAST APPROACH: A PRELIMINARY REPORT OF 45 CASES WITH TOTAL OR NEAR-TOTAL THYROIDECTOMY PLUS CENTRAL COMPARTMENT DISSECTION. AUTHOR(S): H YAN, Y WANG, P HUANG, Y HONG, Q YE, Q XIE, Q ZHAO, P WANG. CITATION: NIGER J CLIN PRACT 2019;22:1772-7; DOI: 10.4103/NJCP.NJCP_120_19. THIS STUDY AIMED TO PRESENT THE 45 CASES WITH SCARLESS NECK ENDOSCOPIC TOTAL OR NEAR-TOTAL THYROIDECTOMY PLUS CCD VIA THE BREAST APPROACH. FROM JAN2011 TO MAR2013, 45 FEMALE PATIENTS (AGE OF 35.5 YEARS [25-50 YEARS]) WITH PAPILLARY THYROID CARCINOMA (PTC) UNDERWENT SCARLESS NECK ENDOSCOPIC THYROIDECTOMY VIA THE BREAST APPROACH. A 5 MM ULTRASONIC COAGULATION DEVICE (HARMONIC SCALPEL, HS; ETHICON ENDOSURGERY, USA) WAS USED TO PERFORM THYROID VESSEL MANAGEMENT AND THYROIDECTOMY. POSTOPERATIVE COMPLICATIONS INCLUDED TRANSIENT VOICE CHANGES (N=9) AND TRANSIENT HYPOPARATHYROIDISM (N=18). IN SUMMARY, THE SCARLESS NECK ENDOSCOPIC TOTAL OR NEAR-TOTAL THYROIDECTOMY PLUS UNILATERAL OR BILATERAL CCD VIA THE BREAST APPROACH FOR SELECTED PTC PATIENTS WAS FEASIBLE AND SAFE, WHEN PERFORMED BY EXPERIENCED THYROID SURGEONS, AND HAD EXCELLENT COSMETIC RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066413 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other