BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 22370645 · Received July 1, 2025

    Report

    Report Number
    3005075853-2025-04923
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    February 1, 2022
    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
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/1/2025 B3: PUBLICATION YEAR OF 2022 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 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: OUTCOMES OF ROBOTIC LIVING DONOR RIGHT HEPATECTOMY FROM 52 CONSECUTIVE CASES COMPARISON WITH OPEN AND LAPAROSCOPY-ASSISTED DONOR HEPATECTOMY AUTHORS: SEOUNG YOON RHO, MD, JAE GEUN LEE, MD, DONG JIN JOO, MD, MYOUNG SOO KIM, MD, SOON IL KIM, MD, DAI HOON HAN, MD, JIN SUB CHOI, MD, PHD, AND GI HONG CHOI, MD, PHD CITATION: ANN SURG (FEB 2022);275(2): E433¿E442. DOI: 10.1097/SLA.0000000000004067. THE AIM OF THISRETROSPECTIVE STUDY IS TO EVALUATE NOT ONLY THE FEASIBILITY AND SAFETY OF ROBOTIC LIVING DONOR RIGHT HEPATECTOMY (RLDRH) IN A RELATIVELY LARGE NUMBER OF CASES BUT ALSO DONOR SATISFACTION OF A PURE MINIMALLY INVASIVE APPROACH COMPARED WITH CONVENTIONAL OPEN DONOR RIGHT HEPATECTOMY (CODRH) AND LAPAROSCOPY-ASSISTED DONOR RIGHT HEPATECTOMY (LADRH). FROM MARCH 2016 TO MARCH 2019, 52 LIVER DONORS (26 MALE AND 26 FEMALE; MEAN AGE OF 28.6±8.7 YEARS) UNDERWENT RLDRH. THE CLINICAL AND PERIOPERATIVE OUTCOMES OF RLDRH WERE COMPARED WITH THOSE OF CODRH (N=62; 39 MALE AND 23 FEMALE; MEAN AGE OF 28.7±8.3 YEARS) AND LADRH (N=118; 74 MALE AND 44 FEMALE; MEAN AGE OF 36.9±12.1 YEARS). DURING THE RLDRH PROCEDURE, THE RIGHT HEPATIC ARTERY AND RIGHT PORTAL VEIN WERE ISOLATED AND CONNECTED TO A VASCULAR LOOP DURING HILAR DISSECTION. THE DIVISION LINE OF THE RIGHT PORTAL VEIN WAS MARKED USING 6-0 PROLENE SUTURE ON THE RIGHT SIDE OF THE PORTAL VEIN BIFURCATION. PARENCHYMAL DISSECTION WAS PERFORMED WITH THE ROBOTIC HARMONIC SCALPEL IN THE LEFT HAND AND A MARYLAND BIPOLAR FORCEPS IN THE RIGHT HAND. THE HARMONIC SCALPEL TRANSECTED THE LIVER PARENCHYMA WITH SMALL BITES AND THE MARYLAND BIPOLAR FORCEPS WERE USED TO DISSECT THE PARENCHYMA, SIMILAR TO THE CLAMP-CRUSH TECHNIQUE IN OPEN SURGERY. EES: REPORTED COMPLICATIONS INCLUDE BILE DUCT INJURY (N=1 MALE PATIENT) AND POSTOPERATIVE COMPLICATIONS GRADE I (N=6) AND II (N=4). ETH REPORTED COMPLICATIONS INCLUDE POSTOPERATIVE COMPLICATIONS GRADE I (N=6) AND II (N=4). IN CONCLUSION, RLDRH RESULTED IN LESS BLOOD LOSS COMPARED WITH THAT OF CODRH AND SIMILAR POSTOPERATIVE COMPLICATION RATES TO CODRH AND LADRH. RLDRH PROVIDED BETTER BODY IMAGE AND COSMETIC RESULTS COMPARED WITH THOSE OF LADRH. RLDRH IS FEASIBLE AND SAFE WHEN PERFORMED BY SURGEONS EXPERIENCED WITH BOTH ROBOTIC AND OPEN HEPATECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1194489 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention