BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 15753568 · Received November 8, 2022

    Report

    Report Number
    3005075853-2022-07671
    Event Type
    Injury
    Date Received
    November 8, 2022
    Date of Event
    May 5, 2022
    Report Date
    November 8, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PUBLICATION YEAR OF 2022. 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: ROBOT-ASSISTED DONOR NEPHRECTOMY: INITIAL RESULTS AND COMPARISON WITH THE HAND-ASSISTED LAPAROSCOPIC TECHNIQUE. A RETROSPECTIVE STUDY. AUTHOR: MIRZA M. IDU AU, FREDERIKE BEMELMAN , AZAM NURMOHAMED, KARLIJN VAN DER PANT. CITATION: INTERNATIONAL JOURNAL OF SURGERY OPEN 43 (2022) 100481. HTTPS://DOI.ORG/10.1016/J.IJSO.2022.100481. THE AIM OF THIS STUDY IS TO EVALUATE FEASIBILITY AND SAFETY OF ROBOTIC-ASSISTED DONOR NEPHRECTOMY (RADN) AS COMPARED WITH THE HAND-ASSISTED LAPAROSCOPIC TECHNIQUE (HALDN). THIS IS A SINGLE CENTER RETROSPECTIVE OBSERVATIONAL STUDY PERFORMED IN THE UNIVERSITY HOSPITAL. THE FIRST RADN IN OUR CENTER WAS PERFORMED IN MARCH 2019, AND THE RADN GROUP CONSIST OF 83 CONSECUTIVE PROCEDURES UNTIL MARCH 2021. THE RADN WERE COMPARED WITH 103 CONSECUTIVE HALDN THAT WERE PERFORMED BETWEEN MARCH 2017 AND MARCH 2021. HARMONIC SHEARS AND PDS 2-0 SUTURE WAS USED. REPORTED COMPLICATIONS INCLUDED IN THE WOUND HERNIAS OCCURRED, CLAVIEN-DINDO GRADE II AND CLAVIEN-DINDO GRADE IIIB. INCONCLUSION RADN IS A SAFE AND EFFECTIVE METHOD FOR DONOR NEPHRECTOMY AS IT HAS COMPARABLE SURGICAL OUTCOMES TO ESTABLISHED STANDARD OF CARE. OUR EXPERIENCE HAS SHOWN THAT THE DA VINCI SURGICAL SYSTEM CAN BE ADOPTED RAPIDLY AND SAFELY IN TRANSPLANT SURGERY. THE COMING PERIODS MULTIPLE SURGICAL ROBOTS WILL BE AVAILABLE ON THE MARKET AND WE WILL PROBABLY PROCEED TO ROBOTIC-ASSISTED SURGERY AS THE NEXT LEVEL OF LAPAROSCOPIC SURGERY. CONTINUOUS EVALUATION OF THESE NEW ROBOTIC TECHNOLOGIES WILL ASSIST IN OPTIMIZING ITS FUNCTIONALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2529806 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

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