BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9613600 · Received January 21, 2020

    Report

    Report Number
    3005075853-2020-00498
    Event Type
    Injury
    Date Received
    January 21, 2020
    Report Date
    December 27, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2012. 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: GASLESS SINGLE INCISION ENDOSCOPIC THYROIDECTOMY. AUTHOR/S: DAWEI CHEN, MD, PHD, KEBAO DING, MD, KAI GUO, MD, HAI HONG, MD. CITATION: JSLS. 2012; 16: 60¿64. DOI: 10.4293/108680812X13291597715989. ENDOSCOPIC THYROIDECTOMY MAKING THE SCAR OUTSIDE THE NECK AREA HAS A COSMETIC APPEAL FOR PATIENTS. BASED ON AN ANTERIOR CHEST WALL APPROACH COMBINED WITH THE GASLESS TECHNIQUE, THE AUTHORS DEVELOPED A NOVEL METHOD FOR GASLESS ENDOSCOPIC THYROIDECTOMY WITH A SINGLE INCISION. FROM MARCH 2009 TO NOVEMBER 2010, 48 PATIENTS (AGE RANGE: 18 TO 56 YEARS OLD; 46 FEMALE AND 2 MALE PATIENTS) WITH BENIGN THYROID NODULES UNDERWENT THYROIDECTOMY WITH THE GASLESS SINGLE-INCISION ENDOSCOPIC SURGERY TECHNIQUE VIA THE ANTERIOR CHEST WALL APPROACH. DURING THE SURGICAL PROCEDURE, THE HARMONIC SCALPEL (ETHICON) WAS USED TO DISSECT AND DIVIDE THE THYROID GLAND AND ITS SURROUNDING CONNECTIVE TISSUES. ONCE THE INFERIOR THYROID VESSELS WERE IDENTIFIED AND ISOLATED, THE VESSELS WERE LIGATED BY THREAD AND THEN DIVIDED BY HARMONIC SCALPEL (ETHICON), OR DIRECTLY DIVIDED BY HARMONIC SCALPEL (ETHICON) CLOSE TO THE THYROID GLAND. THE MEDIAL THYROID VEIN WAS TREATED IN THE SAME WAY. THEN, THE THYROID GLAND WAS RETRACTED MEDIALLY AND UPWARDLY, AND DISSECTION PROCEEDED TO THE POSTERIOR AND LATERAL ASPECTS OF THE GLAND. SUBSEQUENTLY, THE SUBTOTAL THYROID GLAND TOGETHER WITH THE LESION WAS EXCISED WITH THE HARMONIC SCALPEL (ETHICON), AND THE RECURRENT LARYNGEAL NERVE AND PARATHYROID GLANDS WERE LEFT INTACT. REPORTED COMPLICATIONS INCLUDED UNCONTROLLED BLEEDING (N-1) WHICH REQUIRED CONVERTION TO CONVENTIONAL PROCEDURE AND HEMATOMA (N-1). THE ABILITY TO IDENTIFY AND PRESERVE THE RECURRENT LARYNGEAL NERVE DURING ENDOSCOPIC THYROIDECTOMY HAD SUBSEQUENTLY HELPED PREVENT TRANSIENT HOARSENESS. PATIENTS WERE SATISFIED WITH THE SURGERY, BECAUSE THE SCAR IN THE CHEST WALL WAS HIDDEN BY THE PATIENT¿S CLOTHING AND WAS NOT ROUTINELY VISIBLE IN OUR CHINESE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72395 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention