BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_ULTRACISION HARMONIC FOCUS

    MDR report key: 9413915 · Received December 4, 2019

    Report

    Report Number
    3005075853-2019-23981
    Event Type
    Injury
    Date Received
    December 4, 2019
    Report Date
    November 5, 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). BATCH # UNK. DATE OF EVENT: PUBLICATION YEAR OF 2014 FOR JOURNAL ARTICLE. 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: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. PLEASE PROVIDE THE SPECIFIC NUMBER OF PATIENTS IN BOTH THE F AND T GROUP WHO EXPERIENCED PAIN. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REVIEW OF THE JOURNAL ARTICLE, TITLE: THE SAFETY OF THE HARMONIC® FOCUS IN OPEN THYROIDECTOMY: A PROSPECTIVE, RANDOMIZED STUDY COMPARING THE HARMONIC® FOCUS AND TRADITIONAL SUTURE LIGATION (KNOT AND TIE) TECHNIQUE. AUTHOR/S: ANTONIO ZANGHÌ, ANDREA CAVALLARO*, MARIA DI VITA, FRANCESCO CARDÌ, PAOLO DI MATTIA, GAETANO PICCOLO, GIUSEPPINA BARBERA, MARIO URSO, ALESSANDRO CAPPELLANI. CITATION: INTERNATIONAL JOURNAL OF SURGERY (2014); 12: S132ES135. DOI: HTTP://DX.DOI.ORG/10.1016/J.IJSU.2014.05.028. THE OBJECTIVE OF THIS STUDY IS TO ANALYZE THE EXPERIENCE, BASED ON PROSPECTIVELY ACQUIRED DATA, COMPARING THE HARMONIC SCALPEL WITH OTHER HEMOSTATIC TECHNIQUES IN THYROID SURGICAL PATIENTS AND TO ASSESS RELEVANT OUTCOMES SUCH AS OPERATING TIME, BLOOD LOSS, VOLUME OF DRAINAGE FLUID, COMPLICATIONS, POSTOPERATIVE PAIN, AND LENGTH OF HOSPITAL STAY AND, IF FEASIBLE, TO COMPARE OUR RESULTS WITH PROSPECTIVE, RANDOMIZED TRIALS. THIS STUDY WAS CARRIED OUT FROM JANUARY 2010 TO DECEMBER 2011: 83 PATIENTS AFFECTED BY MULTINODULAR NON TOXIC GOITRES, UNDERGONE OPEN THYROIDECTOMY WITHIN THIS PERIOD, WERE INCLUDED IN THIS PROSPECTIVE STUDY. THE PATIENTS WERE RANDOMIZED AND DIVIDED INTO TWO SIMILARLY SIZED GROUPS: THE HARMONIC® FOCUS GROUP (F GROUP) AND TRADITIONAL GROUP (T GROUP). THE GROUP F COMPRISED 41 PATIENTS IN WHOM THE THYROIDECTOMY WERE PERFORMED USING THE ULTRASONICALLY ACTIVATED SCALPEL TECHNOLOGY (HARMONIC FOCUS; ETHICON). THE APPLICATION OF ULTRASOUND TO TISSUES WAS PERFORMED DURING THE ENTIRELY PROCEDURE, TO OBTAIN THREE PURPOSES SYNERGISTICALLY: COAGULATION, CUTTING, AND CAVITATION. THE GROUP T CONSISTED OF 42 PATIENTS IN WHOM DISSECTION AND HEMOSTASIS WERE PERFORMED USING CONVENTIONAL MATERIALS (VICRYL, LIGAPAK 3-0 [ETHICON], STITCHES, TITANIUM HEMOSTATIC CLIPS AND MONOPOLAR OR BIPOLAR ELECTROCAUTERY). REPORTED COMPLICATION IN THE F GROUP INCLUDED RECURRENT LARYNGEAL NERVE (RLN) PALSY (N-2) AND POST OPERATIVE PAIN (VAS) (N-?). REPORTED COMPLICATION IN THE T GROUP INCLUDED RECURRENT LARYNGEAL NERVE (RLN) PALSY (N-1) AND POST OPERATIVE PAIN (VAS) (N-?). IN CONCLUSION, THE HARMONIC FOCUS MAY PROVIDE A COST-EFFECTIVE OPTION ONLY IN HIGH VOLUME CENTERS WHERE REDUCING OPERATIVE TIME MAY BALANCE THE NUMBER OF DAILY PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1207874 UNK_ULTRACISION HARMONIC FOCUS INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other