BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 22373502 · Received July 1, 2025

    Report

    Report Number
    3005075853-2025-04954
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    January 11, 2021
    Report Date
    July 1, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/1/2025. B3: PUBLICATION YEAR OF 2021. D4: BATCH # UNK. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF PUBLISHED SCIENTIFIC ARTICLES CAPTURED UNDER CAPA-014204. 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. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    TITLE: ENDOSCOPIC CEPHALIC ACCESS THYROID SURGERY (ENDOCATS) USING THE RETROAURICULAR APPROACH ¿ A SINGLE CENTRE RETROSPECTIVE DATA ANALYSIS. AUTHORS: THOMAS VON AHNEN, ULRICH WIRTH, MARTIN VON AHNEN, JULIA KROENKE· PETER BUSCH, HANS-MARTIN SCHARDEY, STEFAN SCHOPF. CITATION: SURGICAL ENDOSCOPY (2022) 36:117¿125, HTTPS://DOI.ORG/10.1007/S00464-020-08244-6. THIS STUDY AIMED TO EVALUATE THE PERIOPERATIVE SHORT- AND LONG-TERM OUTCOME AS WELL AS THE LEARNING CURVE OF ENDOCATS AND THE QUALITY OF LIFE (QOL). BETWEEN 2010 AND 2016, A TOTAL OF 150 PATIENTS WITH 152 HEMITHYROIDECTOMIES WHO UNDERWENT ENDOSCOPIC THYROID SURGERY BY ENDOCATS WERE INCLUDED IN THE STUDY. THERE WERE 139 FEMALE AND 11 MALE PATIENTS WITH A MEAN AGE OF 47.08 YEARS (SD ± 11.97; RANGE 21 TO 80 YEARS). DURING THE PROCEDURE, THE HARMONIC SCALPEL (HS) HARMONIC ACE (ETHICON ENDO-SURGERY) WAS USED TO DIVIDE AND SEAL THE VASCULAR PEDICLE AND DIVIDE THE MIDDLE THYROID VEIN. THE INTEGRITY OF RECURRENT LARYNGEAL NERVE, SUPERIOR LARYNGEAL NERVE AND VAGAL NERVE WERE DOCUMENTED BY NERVE MONITORING. THE SKIN WAS CLOSED USING A NON-ETHICON RUNNING SELF-ABSORBABLE SUTURE. THE REPORTED COMPLICATIONS INCLUDED TEMPORARY DYSPHONIA (N=20) AND PERMANENT RECURRENT LARYNGEAL NERVE PALSY (N=3). IN CONCLUSION, ENDOCATS IS A SAFE AND EFFECTIVE, BUT A DEMANDING SINGLE PORT ACCESS PROCEDURE; THEREFORE, EXTENSIVE TRAINING IS REQUIRED. AN ADVANTAGE IS THE NEAR IDEAL VISUALIZATION OF THE RECURRENT LARYNGEAL NERVE AND THE PARATHYROID GLANDS AS WELL AS THE ABILITY TO RECOVER EVEN LARGE SPECIMENS WITHOUT DIFFICULTIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1418793 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention GENERATOR.