BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 22375946 · Received July 1, 2025

    Report

    Report Number
    3005075853-2025-05037
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    September 26, 2013
    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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/1/2025. B3: PUBLICATION YEAR OF 2013. D4: BATCH # UNK. 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. ATTEMPTS WERE 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: THE ARTICLE STATES: "COMPLICATIONS OF "ANASTOMOTIC LEAKAGE" AND "INTRA-ABDOMINAL SEPSIS." HOW IS THE PATIENT DOING NOW AFTER THE REINTERVENTION, LOCAL DRAINAGE AND ANTIBIOTIC THERAPY FOR THE ANASTOMATIC LEAKAGE? WHAT WAS DONE TO TREAT THE INTRA-ABDOMINAL SEPSIS? AND HOW IS THE PATIENT DOING NOW? 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: THE ARTICLE STATES: "COMPLICATIONS OF "ANASTOMOTIC LEAKAGE" AND "INTRA-ABDOMINAL SEPSIS." HOW IS THE PATIENT DOING NOW AFTER THE REINTERVENTION, LOCAL DRAINAGE AND ANTIBIOTIC THERAPY FOR THE ANASTOMATIC LEAKAGE? WHAT WAS DONE TO TREAT THE INTRA-ABDOMINAL SEPSIS? AND HOW IS THE PATIENT DOING NOW? 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: NEW HARMONIC SCALPEL VERSUS CONVENTIONAL HEMOSTASIS IN RIGHT COLON SURGERY: A PROSPECTIVE RANDOMIZED CONTROLLED CLINICAL TRIAL. AUTHOR/S: FEDERICO SISTA A VALENTINA ABRUZZESE A MARIO SCHIETROMA A EMANUELA MARINA CECILIA A ANTONELLA MATTEI B GIANFRANCO AMICUCCI A CITATION: DIG SURG 2013;30:355¿361; DOI: 10.1159/000354864. THIS PROSPECTIVE RANDOMIZED STUDY AIMED TO EVALUATE THE EFFECTIVENESS AND SAFETY OF THE NEW HARMONIC SCALPEL HANDPIECE (NHS) COMPARED WITH CONVENTIONAL HEMOSTATIS (CH) IN OPEN RIGHT COLON SURGERY. FROM JANUARY 2009 TO APRIL 2013, 211 PATIENTS UNDERWENT HEMICOLECTOMY FOR CANCER OF THE RIGHT COLON AND WERE RANDOMIZED INTO TWO GROUPS: NHS GROUP (MALE=58, FEMALE=50; MEAN AGE=70 ± 11 YEARS) AND CH GROUP (MALE=55, FEMALE=48; MEAN AGE=71 ± 9 YEARS). THE OPERATION WAS PERFORMED USING THE NHS (FOCUS LONG CURVED SHEARS, ETHICON). REPORTED COMPLICATION ANASTOMOTIC LEAKAGE (N=4), IN WHICH THE PATIENTS WERE TREATED WITH REINTERVENTION, LOCAL DRAINAGE AND ANTIBIOTIC THERAPY; INTRA-ABDOMINAL SEPSIS (N=1). IN CONCLUSION, NHS IS A USEFUL DEVICE IN COLON SURGERY; IT FACILITATES SURGICAL MANEUVERS AND REDUCES OPERATIVE TIMES AND BLOOD AND LYMPHATIC LOSSES, ALLOWING SATISFACTORY MAINTENANCE OF PROTEIN STORAGE. THIS RESULTS IN A LOWER INCIDENCE OF COMPLICATIONS AND FASTER RECOVERY BY PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381261 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention GENERATOR AND HANDPIECE