BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 22373685 · Received July 1, 2025

    Report

    Report Number
    3005075853-2025-04967
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    September 30, 2020
    Report Date
    July 1, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/1/2025 D4: BATCH # UNK D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY 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 BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. 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

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: RISK FACTORS AND OUTCOMES OF POSTOPERATIVE NECK HEMATOMAS: AN ANALYSIS OF 5,900 THYROIDECTOMIES PERFORMED AT A CANCER CENTER AUTHORS: ANDRE YWATA DE CARVALHO, CAMILA COUTO GOMES, THIAGO CELESTINO CHULAM, JOSE GUILHERME VARTANIAN, GENIVAL BARBOSA CARVALHO, RENAN BEZERRA LIRA, HUGO FONTAN KOHLER, LUIZ PAULO KOWALSKI CITATION: INTERNATIONAL ARCHIVES OF OTORHINOLARYNGOLOGY (2021); 25(3):E421¿E427. DOI HTTPS://DOI.ORG/10.1055/S-0040-1714129 THE AIM OF THIS SINGLE-CENTER RETROSPECTIVE COHORT STUDY IS TO IDENTIFY THE RISK FACTORS FOR POSTTHYROIDECTOMY HEMATOMA REQUIRING REOPERATION, THE TIMING, THE SOURCE OF THE BLEEDING, THE RELATED RESPIRATORY DISTRESS REQUIRING TRACHEOTOMY, AND THE LATE OUTCOMES. BETWEEN JANUARY 1996 TO DECEMBER 2015, A TOTAL OF 5,900 PATIENTS [1074 MALE AND 4826 FEMALE; MEDIAN AGE OF 45.3 YEARS (RANGE: 7¿96 YEARS)] WHO UNDERWENT THYROID SURGERY FOR THYROID DISEASES WERE INCLUDED IN THE STUDY. ENERGY-BASED SURGICAL SEALING DEVICES WERE USED IN 1,505 PATIENTS (25.5%): THE HARMONIC SCALPEL (ETHICON, INC., BRIDGEWATER, NJ, US) IN 1,072 (18.2%), AND A COMPETITOR DEVICE IN 433 PATIENTS (7.3%). IN THE OTHER 4,395 PATIENTS (74.5%), THE CONVENTIONAL HEMOSTASIS TECHNIQUE (COAGULATION WITH ELECTROCAUTERY AND LIGATION OF BLOOD VESSELS) WAS USED. AN ADJUNCTIVE HEMOSTATIC AGENT SURGICEL (ETHICON, INC.), AND A SURGICAL DRAIN WERE USED IN 1,631 (27.6%) AND 2,327 PATIENTS (41.8%) RESPECTIVELY. COMPLICATION INCLUDES POSTOPERATIVE INFECTION (N=103). IN CONCLUSION, HEMATOMA AFTER THYROID SURGERY IS AN UNCOMMON COMPLICATION, BUT IT IS RELATED TO SIGNIFICANT POSTOPERATIVE MORBIDITY. A BETTER UNDERSTANDING OF THE RISK FACTORS AND OF THE TIME UNTIL HEMATOMA FORMATION CAN HELP TARGET HIGH-RISK PATIENTS FOR PREVENTIVE MEASURES AND CLOSER POSTOPERATIVE OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1206363 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention GENERATOR