BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_ULTRACISION HARMONIC FOCUS

    MDR report key: 9470629 · Received December 14, 2019

    Report

    Report Number
    3005075853-2019-24336
    Event Type
    Injury
    Date Received
    December 14, 2019
    Report Date
    November 18, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2015. 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. ADDITIONAL INFORMATION REQUESTED AND THE FOLLOWING WAS OBTAINED: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. INFORMATION NOT AVAILABLE

    Description of Event or Problem · 1

    TITLE: THE USE OF ENERGY DEVICES FOR THYROID SURGICAL PROCEDURES. HARMONIC FOCUS VERSUS BICLAMP 150. AUTHORS: PAOLO DEL RIO, GIOVANNI LAZZARI, MATTEO ROSSINI, PIERCOSIMO NISI, GENNARO PERRONE, ELENA BONATI, MARIO SIANESI. CITATION: ANN. ITAL. CHIR., 2015, 86: 553-559. THE AIM OF THIS PROSPECTIVE STUDY WAS TO EVALUATE THE SAFETY, EASE OF USE, INCIDENCE OF ADVERSE EFFECTS AND COST OF THE DEVICES IN THYROID SURGERY. FROM DECEMBER 05, 2013 TO MAY 29, 2014, 80 PATIENTS UNDERWENT TOTAL THYROIDECTOMY WITH CONVENTIONAL TECHNIQUE USING REUSABLE VS DISPOSABLE DEVICES (BICLAMP 150 ¿ GROUP A VS HARMONIC FOCUS ¿ GROUP B). THE PATIENTS WERE DIVIDED INTO TWO GROUPS: 40 PATIENTS WERE UNDER GROUP A (FEMALE=31, MALE=9; AGE RANGE=57.10 ± 12.39) AND 40 PATIENTS WERE UNDER GROUP B (FEMALE=32, MALE=8; AGE RANGE=55.03 ± 13.79). HARMONIC FOCUS (ETHICON) WAS USED DURING THE PROCEDURE. REPORTED COMPLICATIONS IN GROUP A INCLUDED DYSPHAGIA (N=?); DYSPHONIA (N=?); POST-OP PAIN (N=?). IN CONCLUSION, BOTH DEVICES ARE EFFECTIVE AND SAFE FOR TOTAL THYROIDECTOMY BECAUSE THEY HAVE SIMILAR EFFECTS ON THE OPERATIVE TIME, POSTOPERATIVE BLEEDING, AND PATIENT OUTCOMES IN ENDOCRINE EXPERIENCED SURGICAL TEAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265282 UNK_ULTRACISION HARMONIC FOCUS INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other