BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 17482606 · Received August 8, 2023

    Report

    Report Number
    3005075853-2023-05601
    Event Type
    Injury
    Date Received
    August 8, 2023
    Date of Event
    November 12, 2022
    Report Date
    August 8, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 8/8/2023. B3: PUBLICATION YEAR OF 2022. D4: BATCH # UNK. 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

    TITLE: COMPARISON OF SURGICAL OUTCOMES AND LEARNING CURVE FOR ROBOTIC VERSUS LAPAROSCOPIC LIVING DONOR HEPATECTOMY: A RETROSPECTIVE COHORT STUDY. AUTHOR(S): NA REUM KIM, DAI HOON HAN, GI HONG CHOI, JAE GEUN LEE, DONG JIN JOO, MYOUNG SOO KIM, JIN SUB CHOI. CITATION: INTERNATIONAL JOURNAL OF SURGERY 108 (2022) 107000; HTTPS://DOI.ORG/10.1016/J.IJSU.2022.107000 . THIS STUDY AIMED TO COMPARE SURGICAL OUTCOMES OF ROBOTIC AND LAPAROSCOPIC DONOR RIGHT HEMIHEPATECTOMY PERFORMED BY TWO SURGEONS WITH EXPERTISE IN BOTH TECHNIQUES AT A SINGLE INSTITUTION. BETWEEN MARCH 2016 AND MARCH 2022, A TOTAL OF 171 PATIENTS WHO UNDERWENT MINIMALLY INVASIVE LIVING DONOR HEPATECTOMY WERE INCLUDED IN THE STUDY. THE PATIENTS WERE DIVIDED INTO 2 GROUPS, THE LAPAROSCOPIC LIVING DONOR RIGHT HEMIHEPATECTOMY (LLDRH) GROUP (69 PATIENTS) AND ROBOTIC LIVING DONOR RIGHT HEMIHEPATECTOMY (RLDRH) GROUP (102 PATIENTS). THE RLDRH GROUP IS COMPOSED OF 47 MALES AND 55 FEMALES WITH A MEAN AGE OF 30.7 +/-9.4 YEARS AND A MEAN BMI OF 22.8 +/-2.5 YEARS. THE LLDRH GROUP IS COMPOSED OF 33 MALES AND 36 FEMALES WITH A MEAN AGE OF 30.4 +/-10.6 YEARS AND A MEAN BMI OF 22.7 +/- 2.7 YEARS. DURING THE LAPAROSCOPIC LIVING DONOR RIGHT HEMIHEPATECTOMY PROCEDURE, THE RIGHT LOBE IS MOBILIZED BY DIVIDING THE ROUND, FALCIFORM, CORONARY, AND RIGHT TRIANGULAR LIGAMENTS USING EITHER THE COMPETITOR BOVIE ELECTROCAUTERY DEVICE (MANUFACTURER: UNKNOWN), OR THE COMPETITOR SONICISION CURVED JAW CORDLESS ULTRASONIC DISSECTION SYSTEM (MANUFACTURER: MEDTRONIC) OR HARMONIC HD 1000I (ETHICON ENDO-SURGERY). THE REST OF THE LAPAROSCOPIC LIVING DONOR RIGHT HEMIHEPATECTOMY PROCEDURE WAS COMPLETED USING VARIOUS COMPETITOR DEVICES. MEANWHILE, THE ROBOTIC LIVING DONOR RIGHT HEMIHEPATECTOMY PROCEDURE WAS NOT DESCRIBED IN THIS ARTICLE AS WELL AS THE SURGICAL PROCEDURES INVOLVING THE RECIPIENTS. THE REPORTED COMPLICATIONS INCLUDED UNSPECIFIED GRADE III CLAVIEN¿DINDO CLASSIFICATION SYSTEM COMPLICATION (N=?) AND UNSPECIFIED MAJOR CLAVIEN¿DINDO CLASSIFICATION SYSTEM COMPLICATION (N=?). IN CONCLUSION, ROBOTIC LIVING DONOR RIGHT HEMIHEPATECTOMY RESULTED IN LESS INTRAOPERATIVE BLEEDING AND COMPARABLE POSTOPERATIVE OUTCOMES THAN LAPAROSCOPIC LIVING DONOR RIGHT HEMIHEPATECTOMY. MOREOVER, SINCE 2019, ROBOTIC LIVING DONOR RIGHT HEMIHEPATECTOMY HAS BEEN EMPLOYED MORE FREQUENTLY FOR DONORS WITH HILAR STRUCTURE ANATOMIC VARIATIONS. BASED ON OUR SINGLE-CENTER EXPERIENCE, WE PROPOSE THAT STANDARDIZED PROCEDURES FOR ROBOTIC LIVING DONOR RIGHT HEMIHEPATECTOMY MIGHT HELP SET UP PURE MINIMALLY INVASIVE PROCEDURES FOR DONOR HEPATECTOMY AND FACILITATE SAFE IMPLEMENTATION OF LAPAROSCOPIC APPROACHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1968095 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention