BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL HANDPIECES (EXACT CODE UNKNOWN)

    MDR report key: 9376371 · Received November 26, 2019

    Report

    Report Number
    3005075853-2019-23765
    Event Type
    Injury
    Date Received
    November 26, 2019
    Date of Event
    January 1, 2008
    Report Date
    October 31, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    LFL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER IS UNKNOWN. THEREFORE, THE 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT MEDICAL PRODUCT: UNKNOWN. (B)(4). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DATE OF EVENT: PUBLICATION YEAR OF 2008. 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. (B)(4).

    Description of Event or Problem · 1

    TITLE: THE HARMONIC SCALPEL TECHNIQUE WITHOUT SUPPLEMENTARY LIGATION IN TOTAL THYROIDECTOMY WITH CENTRAL NECK DISSECTION: A PROSPECTIVE RANDOMIZED STUDY. AUTHOR: YOON WOO KOH, MD; JAE HONG PARK, MD; SEUNG WON LEE, MD; AND EUN CHANG CHOI, MD, PHD. CITATION: ANN SURG 2008;247: 945¿949; DOI: 10.1097/SLA.0B013E31816BCD61. THIS PROSPECTIVE RANDOMIZED STUDY AIMED TO INVESTIGATE THE SAFETY AND EFFICACY OF THE NO-TIE (NT) TECHNIQUE USING THE HARMONIC SCALPEL (HS) IN TERMS OF THE OPERATING TIME AND COMPLICATIONS IN TOTAL THYROIDECTOMY WITH CENTRAL NECK DISSECTION (CND). BETWEEN OCT2006 AND FEB2007, 65 PATIENTS WITH THYROID PAPILLOMA CARCINOMA UNDERWENT TOTAL THYROIDECTOMY WITH CND USING TWO DIFFERENT TECHNIQUES: NT TECHNIQUE USING HARMONIC SCALPEL (N=31; N=29 FEMALE AND N=2 MALE; MEAN AGE OF 49±12.6 YEARS) AND CONVENTIONAL HAND-TIED LIGATION TECHNIQUE (N=34; N=31 FEMALE AND N=3 MALE; MEAN AGE OF 47.71±13.46 YEARS). IN NT TECHNIQUE GROUP, ONLY THE HS WITH THE CS-14C HANDPIECE (JOHNSON & JOHNSON MEDICAL, CINCINNATI, OH) WAS USED FOR VASCULAR CONTROL OF THE THYROID GLAND. FOR BETTER HEMOSTASIS, THE SUPERIOR, MIDDLE, AND INFERIOR THYROIDAL ARTERIES AND VEINS WERE CONTROLLED USING A LOW-POWER LEVEL (70 UM VIBRATION). THE OTHER SMALL VESSELS AND SURROUNDING CONNECTIVE TISSUES WERE CONTROLLED USING A HIGHER POWER LEVEL (100 UM VIBRATION) FOR EASY CUTTING. THE WOUND WAS CLOSED USING 4¿0 VICRYL AND 5¿0 NYLON. POSTOPERATIVE COMPLICATIONS IN NT GROUP INCLUDED TRANSIENT UNILATERAL RECURRENT LARYNGEAL NERVE PALSY (N=2) WHICH RESOLVED SPONTANEOUSLY BY 8 WEEKS POSTOPERATIVELY, AND SEROMA (N=3) WHICH RESOLVED WITH REPEATED NEEDLE ASPIRATION AND COMPRESSION DRESSINGS. IT WAS SPECULATE THAT THE TRANSIENT HYPOCALCEMIA WAS CAUSED BY MECHANICAL FACTORS (STRETCHING, PINCHING) OR PERIOPERATIVE HEMODILUTION WITH INCREASED RENAL EXCRETION OF THE CALCIUM AND INCREASED RELEASE OF CALCITONIN, AS NOTED BY OTHER STUDIES. THE TRANSIENT VOCAL CORD PALSIES MIGHT HAVE RESULTED FROM MANIPULATION OF THE THYROID GLAND, POSTOPERATIVE INFLAMMATION, OR EDEMA. THE FINDINGS SUGGEST THAT APPLICATION OF THE NT TECHNIQUE USING THE HS IS A RELATIVELY SAFE METHOD, EVEN IN TOTAL THYROIDECTOMY COMBINED WITH CND, AND IT REDUCES THE OPERATING TIME BY SIMULTANEOUSLY LIGATING AND CUTTING THE VESSELS WITH SUFFICIENT HEMOSTASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173029 HARMONIC SCALPEL HANDPIECES (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention