BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 23110054 · Received September 22, 2025

    Report

    Report Number
    3005075853-2025-07497
    Event Type
    Injury
    Date Received
    September 22, 2025
    Date of Event
    March 1, 2025
    Report Date
    September 22, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 9/22/2025. B3: PUBLICATION YEAR OF 2025. D4: BATCH#: UNK. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. 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. 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

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KIM NR, HAN DH, JOO DJ, LEE JG, KIM DG, KIM MS, CHOI JS, CHOI GH. PROPENSITY SCORE-MATCHED DONOR AND RECIPIENT OUTCOMES: ROBOTIC VERSUS LAPAROSCOPIC DONOR RIGHT HEPATECTOMY. TRANSPLANTATION. 2025 MAR 1;109(3): E166-E174. DOI: 10.1097/TP.0000000000005245. EPUB 2024 OCT 23. PMID: 39439020. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO COMPARE SHORT-TERM AND TOTAL FOLLOW-UP OUTCOMES BETWEEN DONORS AND RECIPIENTS OF LAPAROSCOPIC DONOR RIGHT HEPATECTOMY (LDRH) AND ROBOTIC DONOR RIGHT HEPATECTOMY (RDRH) AT A SINGLE INSTITUTION. BETWEEN MARCH 2016 AND JUNE 2023, A TOTAL OF 235 DONORS WHO UNDERWENT RIGHT HEPATECTOMY FOR LIVING DONOR LIVER TRANSPLANTATION (LDLT) WERE INCLUDED. AMONG THESE PATIENTS, 117 PATIENTS (55 MALE AND 62 FEMALE; MEAN AGE OF 30.5 ± 9.4 YEARS) UNDERWENT RDRH STARTING AND 118 PATIENTS (58 MALE AND 60 FEMALE; MEAN AGE OF 32.2 ± 10.9 YEARS) UNDERWENT LDRH. SPECIFICALLY, RDRH USES A HARMONIC SCALPEL AND MARYLAND BIPOLAR FORCEPS, WHEREAS LDRH USES A CAVITRON ULTRASONIC SURGICAL ASPIRATOR AS THE MAIN DEVICE. DURING BD DIVISION, THE RDRH USES A ROBOTIC FIREFLY SYSTEM WITH 3D VISION; HOWEVER, LDRH SWITCHES TO A 2-DIMENSIONAL (2D) NEAR-INFRARED CAMERA FROM A 3D FLEXIBLE CAMERA TO CONFIRM THE BIFURCATION AND STRUCTURE OF THE BD USING INDOCYANINE GREEN (ICG). THE BD DIVISION FOLLOWS THE PREVIOUSLY REPORTED TECHNIQUE KNOWN AS ¿CLIP AND CUT¿ (FIGURE 1A AND B). IN MOST CASES, THE RIGHT HEPATIC DUCT WITH THE HILAR PLATE WAS ISOLATED, AND HEM-O-LOK (GRENA, LONDON, UNITED KINGDOM) WAS APPLIED. THE BD WAS THEN DIVIDED WITH A 1MM SAFETY MARGIN FROM THE SITE WHERE THE HEM-O-LOK WAS APPLIED. THE STUMP OF THE RIGHT HEPATIC DUCT, WHERE THE HEM-O-LOK WAS APPLIED, WAS REINFORCED USING A 6-0 MONOFILAMENT SUTURE (PROLENE POLYPROPYLENE SUTURE; ETHICON INC., JOHNSON & JOHNSON MEDICAL SPA, SOMERVILLE, NJ). RECENTLY, THE BD DIVISION PROCEDURE WAS MODIFIED, REFERRED TO AS ¿CUT AND SUTURE¿ (FIGURE 1C¿F) FOR SELECTED CASES WITH A SHORT RIGHT HEPATIC DUCT. IN THESE INSTANCES, THE BD WAS FIRST ISOLATED AND DIVIDED WITH SCISSORS, AND THEN THE OPENING WAS CLOSED WITH CONTINUOUS SUTURING USING A 6-0 NONABSORBABLE SUTURE. REPORTED COMPLICATIONS OF DONORS INCLUDE GRADE IIIA (N=6) AND GRADE IV (N=1). IN CONCLUSION, RDRH DEMONSTRATED COMPARABLE POSTOPERATIVE COMPLICATIONS TO LDRH IN DONORS BUT SHOWED FEWER RECIPIENT BILIARY COMPLICATIONS. THIS COULD BE ATTRIBUTED TO THE PRECISION OF ROBOTIC DISSECTION AND BD DIVISION, RESULTING IN FEWER MULTIPLE BD OPENINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2510970 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention