BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 10575201 · Received September 23, 2020

    Report

    Report Number
    3005075853-2020-04860
    Event Type
    Injury
    Date Received
    September 23, 2020
    Report Date
    August 28, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    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. WHAT IS THE CORRECT PATIENT DEMOGRAPHICS FOR THE BOTH HARMONIC SCALPEL AND CONVENTIONAL TECHNIQUE AS THE DATA FROM THE ABSTRACT AND METHOD DOES NOT MATCH THE DATA FROM THE RESULTS. DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN.

    Description of Event or Problem · 1

    TITLE: THE USE OF THE HARMONIC SCALPEL IN THYROID SURGERY. OUR EXPERIENCE AUTHOR(S): ARIF RAZA KHAN, MUHAMMAD RASHID WAHEED, MUHAMMAD ASAD ULLAH ARIF CITATION: MED SCI 2019; 27: (2) 142-146; THIS PROSPECTIVE STUDY AIMED TO EVALUATE THE POTENTIAL ADVANTAGES OF THE USE OF HARMONIC SCALPEL IN THYROIDECTOMIES IN TERMS OF OPERATIVE TIME AND COMPLICATIONS. FROM JAN2017 TO MAR2019, 115 PATIENTS WITH THYROID BENIGN AND MALIGNANT NODULES UNDERWENT HEMITHYROIDECTOMY AND TOTAL THYROIDECTOMY. THESE PATIENTS WERE DIVIDED INTO TWO GROUPS BASED ON THE TECHNIQUE USED: THE CONVENTIONAL TECHNIQUE (N=47; N=40 HEMITHYROIDECTOMY AND N=7 TOTAL THYROIDECTOMY) AND HARMONIC SCALPEL GROUP (N=68; N=60 HEMITHYROIDECTOMY AND N=8 TOTAL THYROIDECTOMY). IN HARMONIC SCALPEL GROUP, THE SUPERIOR AND INFERIOR THYROID VESSELS WERE THE DIVIDED WITH THE HARMONIC SCALPEL WITH THE CS-14C HANDPIECE (HARMONIC SYNERGY CURVED BLADE). IN HARMONIC SCALPEL GROUP, HYPOPARATHYROIDISM WAS PRESENT IN 34 PATIENTS AT DISCHARGE, IN 23 AT 6 MONTHS AND IN 10 AT 10 MONTHS. ONLY 1 PATIENT SHOWED TRANSIENT LARYNGEAL NERVE PALSY AFTER TOTAL THYROIDECTOMY WITH CENTRAL NECK DISSECTION WITH HS. THE USE OF HARMONIC SCALPEL IN THYROID SURGERY IS SAFE AND EFFECTIVE AND IS ASSOCIATED WITH A SIGNIFICANT REDUCTION IN OPERATIVE TIME, POSTOPERATIVE HYPOCALCAEMIA AND HOSPITAL STAY, WITHOUT INCREASING COMPLICATIONS RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035976 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other GENERATOR AND HANDPIECE