BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 8890423 · Received August 13, 2019

    Report

    Report Number
    3005075853-2019-21213
    Event Type
    Injury
    Date Received
    August 13, 2019
    Report Date
    July 19, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CORRECTED DATA: CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: GENERATOR AND HANDPIECE.

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. DATE OF EVENT IS UNKNOWN. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, A MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REVIEW OF A JOURNAL ARTICLE, TITLE: TRANSORAL ENDOSCOPIC THYROIDECTOMY FOR PAPILLARY THYROID MICROCARCINOMA: INITIAL EXPERIENCE OF A SINGLE SURGEON. AUTHOR/S: YOUNG JUN CHAI*, JUNG KEE CHUNG*, ANGKOON ANUWONG1, GIANLORENZO DIONIGI2, HOON YUB KIM3, KI-TAE HWANG, SEUNG CHUL HEO, KA HEE YI4, KYU EUN LEE5. CITATION: ANN SURG TREAT RES 2017;93(2):70-75 / HTTPS://DOI.ORG/10.4174/ASTR.2017.93.2.70. THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO PRESENT THE SURGICAL PROCEDURES AND INITIAL OUTCOMES OF TOET IN THE TREATMENT OF PAPILLARY THYROID MICROCARCINOMA (PTMC) PATIENTS. BETWEEN JUL 2016 AND FEB 2017, A TOTAL OF 10 FEMALE PATIENTS (MEAN AGE 43.3 ± 11.5 YEARS, MEAN BMI 24.6 ± 8.9 KG/M2) WERE INCLUDED IN THE STUDY. SEVEN PATIENTS UNDERWENT THYROID LOBECTOMY AND 3 PATIENTS UNDERWENT ISTHMUSECTOMY. IN ALL PATIENTS, THEY LIFTED THE SUPERIOR POLE OF THE THYROID GLAND AND LIGATED SUPERIOR THYROIDAL VESSELS WITH A HARMONIC ACE +7 (ETHICON). POSTOPERATIVE COMPLICATION INCLUDED TRANSIENT VOCAL CORD PALSY (N=2); VOCAL CORD MOVEMENT RECOVERED WITHIN 3 MONTHS AFTER THE OPERATION. TOET WAS FEASIBLE AND COULD BE PERFORMED SAFELY FOR PTMC. TOET MIGHT BECOME A NEW TREATMENT OPTION FOR THE PATIENTS WHO DO NOT WANT TO LEAVE VISIBLE SCARS ON THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685056 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other GENERATOR AND HANDPIECE