BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9462325 · Received December 12, 2019

    Report

    Report Number
    3005075853-2019-24246
    Event Type
    Injury
    Date Received
    December 12, 2019
    Report Date
    November 14, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. DATE OF EVENT: PUBLICATION YEAR FOR THE JOURNAL ARTICLE IS 2010. 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. THIS COMPLAINT HAS BEEN DOCUMENTED BASED ON THE INFORMATION AVAILABLE WITHIN THE ARTICLE; HOWEVER, DUE TO THE AGE OF THE JOURNAL ARTICLE, ADDITIONAL EVENT DETAILS WILL NOT BE PURSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REVIEW OF JOURNAL ARTICLE, TITLE: MINIMALLY INVASIVE VIDEO-ASSISTED THYROIDECTOMY: EXPERIENCE OF 300 CASES. . AUTHOR/S: YOUBEN FAN, BOMIN GUO, SHUNLI GUO, JIE KANG, BO WU, PIN ZHANG, QI ZHENG. CITATION: SURG ENDOSC (2010) 24:2393¿2400; DOI 10.1007/S00464-010-0960-Y. THIS STUDY AIMED TO SUMMARIZE THE SAFETY AND FEASIBILITY OF MINIMALLY INVASIVE VIDEO-ASSISTED THYROIDECTOMY (MIVAT). FROM FEBRUARY 2005 TO AUGUST 2008, A TOTAL OF 300 PATIENTS (N=36 MALE N=264 FEMALE, MEAN AGE: 54.6 YEARS, RANGE: 23-71 YEARS) UNDERWENT MIVAT USING A SINGLE CENTRAL INCISION WITH AN AVERAGE LENGTH OF 2 CM (RANGE = 1.5¿3 CM), ABOUT 2 CM ABOVE THE STERNAL NOTCH. SMALL CONVENTIONAL RETRACTORS AND DISSECTORS, ULTRASONIC SCALPEL (ETHICON), 5-MM LAPAROSCOPE, AND A VIDEO SCREEN WERE THE INSTRUMENTS USED. THE ULTRASONIC SCALPEL (ETHICON) WAS USED TO DISSECT THE MIDDLE THYROID VEIN AND THE UPPER AND LOWER POLE VESSELS. ALSO, UNDER DIRECT VISION, THE BACK OF THE THYROID LOBE WAS DISSECTED COMPLETELY WITH THE ULTRASONIC SCALPEL. IF BLOOD WAS STILL OOZING FROM THE RESIDUAL THYROID TISSUES, ULTRASONIC SCALPEL OR RESORBABLE STITCHES WERE USED FOR HEMOSTASIS. COMPLAINTS INCLUDED MASSIVE HEMORRHAGE FROM THE VESSELS OF THE UPPER PEDUNCLE (N=1). THIS PATIENT WAS CONVERTED TO OPEN SURGERY. OTHER OPERATIVE COMPLAINTS INCLUDED PERMANENT UNILATERAL RECURRENT LARYNGEAL NERVE (RLN) PALSY (N=5), TRANSIENT UNILATERAL RLN PALSY (N=7), SUPERIOR LARYNGEAL NERVE (SLN) INJURY (N=5), TRANSIENT HYPOPARATHYROIDISM (N=9), AND MILD SKIN BURN FROM THE ULTRASONIC SCALPEL (N=5). IN CONCLUSION, MIVAT APPEARS TO BE SAFE AND FEASIBLE IN PATIENTS WITH BENIGN THYROID NODULES, WITH MINIMAL INJURY AND EXCELLENT COSMETIC RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257798 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention