BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 22372214 · Received July 1, 2025

    Report

    Report Number
    3005075853-2025-04550
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    June 2, 2021
    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
    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: SAFETY AND FEASIBILITY OF ROBOTIC LIVER RESECTION AFTER PREVIOUS ABDOMINAL SURGERIES. AUTHORS: LINDA FELDBRÜGGE, SANTIAGO ANDRES ORTIZ GALINDO, OLIVER FRISCH, CHRISTIAN BENZING, FELIX KRENZIEN, ANNA RIDDERMANN, ANIKA KÄSTNER, NORA FRANZISKA NEVERMANN, THOMAS MALINKA, WENZEL SCHÖNING, JOHANN PRATSCHKE, MORITZ SCHMELZLE CITATION CITE: SURGICAL ENDOSCOPY (2022) 36:2842¿2849. HTTPS://DOI.ORG/10.1007/S00464-021-08572-1. THE AIM OF THIS STUDY WAS TO DETERMINE WHETHER PREVIOUS ABDOMINAL SURGERY SHOULD BE A CONTRAINDICATION FOR ROBOTIC SURGERY. CLINICAL DATA OF ALL CONSECUTIVE ROBOTIC RESECTIONS AT OUR CENTER, USING THE DA VINCI XI SURGICAL SYSTEM, BETWEEN APRIL 2018 AND DECEMBER 2020, WERE COLLECTED AND ANALYZED AS PART OF A PROSPECTIVE, POST-MARKETING OBSERVATIONAL STUDY. PRIOR ABDOMINAL SURGERIES WERE SPECIFIED ACCORDING TO THE SURGICAL APPROACH AND LOCALIZATION. BASELINE AND PERIOPERATIVE OUTCOME CRITERIA WERE COMPARED BETWEEN PATIENTS WITH PRIOR SURGERIES (PS) AND PATIENTS WITH NO PRIOR SURGERIES (NPS) IN UNIVARIATE AND MULTIVARIATE ANALYSES. LIVER PARENCHYMA WAS DISSECTED IN A MODIFIED CLAMP CRUSH TECHNIQUE USING HARMONIC ACE® (ETHICON, MN, USA), WHILE LARGE VESSELS WERE EITHER CLIPPED OR TRANSECTED USING STAPLERS (ECHELON, JOHNSON & JOHNSON, USA). REPORTED COMPLICATION INCLUDED CLAVIEN DINDO GRADE III (N=27). IN CONCLUSION WE PROPOSE ROBOTIC LIVER RESECTION TO BE SAFE AND FEASIBLE, INCLUDING IN PATIENTS WITH PRIOR ABDOMINAL SURGERIES. EACH PATIENT SHOULD BE EVALUATED FOR A MINIMALLY INVASIVE PROCEDURE REGARDLESS OF A HISTORY OF PREVIOUS OPERATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1313415 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention GENERATOR