BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 9476613 · Received December 16, 2019

    Report

    Report Number
    3005075853-2019-24371
    Event Type
    Injury
    Date Received
    December 16, 2019
    Report Date
    November 21, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K042777
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 12/16/2019. DATE OF EVENT: PUBLICATION YEAR OF 2010. 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.

    Description of Event or Problem · 1

    TITLE: CLIPLESS AND SUTURELESS ENDOSCOPIC THYROIDECTOMY USING ONLY THE HARMONIC SCALPEL. AUTHOR/S: YOON WOO KOH, JAE HONG PARK, JAE WOOK KIM, SEUNG WON LEE, EUN CHANG CHOI. CITATION: SURG ENDOSC (2010) 24:1117¿1125; DOI 10.1007/S00464-009-0738-2. THIS RETROSPECTIVE ANALYSIS STUDY AIMED TO ASSESS THE SAFETY AND EFFICACY OF THE CLIPLESS AND SUTURELESS TECHNIQUE USING THE HARMONIC SCALPEL (HS) IN ENDOSCOPIC THYROIDECTOMY WITHOUT SUPPLEMENTARY INSTRUMENTATION. BETWEEN JAN2007 AND SEP2008, 114 PATIENTS (N=101 FEMALE AND N=13 MALEL MEAN AGE OF 40.32±9.71 YEARS [RANGED 15-60 YEARS]) UNDERWENT ENDOSCOPIC HEMITHYROIDECTOMY (HT) (N=92) AND ENDOSCOPIC TOTAL THYROIDECTOMY (TT) (N=22) FOR FOLLICULAR ADENOMA (N=24), NODULAR HYPERPLASIA (N=87) AND LYMPHOCYTIC THYROIDITIS (N=3). IN ALL CASES, ONLY THE HS (HARMONIC ACE 36P; JOHNSON & JOHNSON MEDICAL, (B)(4), USA) WAS USED FOR VASCULAR CONTROL OF THE THYROID GLAND AND THE STRAP MUSCLES. AFTER ELEVATION OF THE SKIN FLAP WITH THE MONOPOLAR CAUTERIZATION, WE USED ONLY THE HS AND AN ENDOSCOPIC DISSECTOR FOR VESSEL SEALING AND TISSUE DISSECTION THROUGHOUT THE OPERATION. SUBCUTANEOUS WOUND CLOSURE WAS ACHIEVED WITH 4-0 VICRYL. POSTOPERATIVELY, COMPLICATION INCLUDED TRANSIENT UNILATERAL VOCAL CORD PALSY (N=4 HT GROUP AND N=1 TT GROUP) WHICH RESOLVED SPONTANEOUSLY BY 3 MONTHS. THE AUTHORS SPECULATED THAT THIS TRANSIENT VOCAL CORD PALSY WAS RELATED TO MANIPULATION OF THE THYROID GLAND, POSTOPERATIVE INFLAMMATION, EDEMA, OR TRACTION INJURY DURING DISSECTION OF THE RECURRENT LARYNGEAL NERVE. CAREFUL DISSECTION WITH THE ENDOSCOPIC COTTONOID AND THE HS IS ESSENTIAL WHILE THE THYROID IS DISSECTED FROM THE TRACHEA TO MINIMIZE REMNANT THYROID TISSUE NEAR BERRY¿S LIGAMENT. IT WAS SPECULATED THAT THE TRANSIENT HYPOCALCEMIA WAS CAUSED BY MECHANICAL FACTORS (STRETCHING, PINCHING) OR PERIOPERATIVE HEMODILUTION WITH INCREASED RENAL EXCRETION OF CALCIUM AND INCREASED RELEASE OF CALCITONIN. THE HEMATOMAS AROSE FROM THE SKIN FLAP, ELEVATED WITH A MONOPOLAR COAGULATOR. THE HIGH FREQUENCY OF THE SEROMAS IN THIS STUDY MAY HAVE RESULTED FROM THE WIDE SKIN FLAP ELEVATION AND THE CREATION OF A LARGE WORKING SPACE FROM THE AXILLA TO THE THYROID GLAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271666 HARMONIC ACE 36 CM INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other