BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 10600147 · Received September 29, 2020

    Report

    Report Number
    3005075853-2020-05013
    Event Type
    Injury
    Date Received
    September 29, 2020
    Report Date
    September 2, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PUBLICATION YEAR OF 2020. 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. 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 · 1

    TITLE: INITIAL EXPERIENCE WITH UNIPORTAL VIDEO-ASSISTED THORACOSCOPIC SURGERY FOR THE TREATMENT OF LUNG CANCER PERFORMED BY A SURGEON WHO DID NOT HAVE PREVIOUS EXPERIENCE PERFORMING MULTIPORTAL THORACOSCOPIC SURGERY: A SINGLE CENTER RETROSPECTIVE STUDY. AUTHORS: YOUNGKYU MOON CITATION: J THORAC DIS 2020;12(5):1972-1981. DOI: 10.21037/JTD-20-242. THE AIM OF THIS RETROSPECTIVE STUDY IS TO EVALUATE THE SURGICAL OUTCOME OF UNIPORTAL VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) FOR THE TREATMENT OF NON-SMALL CELL LUNG CANCER PERFORMED BY A SURGEON WHO DID NOT HAVE PREVIOUS EXPERIENCE PERFORMING OPEN THORACOTOMY AND MULTIPORTAL VATS. BETWEEN JAN 2017 AND DEC 2018, 85 PATIENTS (N=32 MALE AND N=53 FEMALE WITH MEAN AGE OF 63.66 YEARS) DIAGNOSED WITH NON-SMALL CELL LUNG CANCER (NSCLC) UNDERWENT UNIPORTAL VATS ANATOMICAL PULMONARY RESECTION. DURING THE PROCEDURE, SMALL VESSELS WERE LIGATED WITH SILK STRING OR CLIPS AND DIVIDED WITH THE ENERGY DEVICE (HARMONIC ACE). THE LYMPH NODES WERE DISSECTED USING A NONGRASPING TECHNIQUE, WHICH INVOLVED DISSECTION OF THE SURROUNDING TISSUE WITH AN ENERGY DEVICE (HARMONIC ACE). POSTOPERATIVE COMPLICATION INCLUDED POSTOPERATIVE BLEEDING (N=2) AND CHYLOTHORAX (N=2). ALL COMPLICATIONS WERE COMPLETELY RESOLVED BEFORE DISCHARGE FROM THE HOSPITAL. IN CONCLUSION, SURGICAL OUTCOMES OF UNIPORTAL VATS FOR PULMONARY ANATOMIC RESECTION FOR THE TREATMENT OF LUNG CANCER PERFORMED BY A SURGEON WITH LIMITED PREVIOUS EXPERIENCE WERE NOT INFERIOR TO THOSE OF MULTIPORTAL VATS PERFORMED BY EXPERIENCED SURGEONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064561 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other GENERATOR AND HANDPIECE