BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE + 7

    MDR report key: 17003612 · Received May 25, 2023

    Report

    Report Number
    3005075853-2023-03545
    Event Type
    Injury
    Date Received
    May 25, 2023
    Date of Event
    May 13, 2022
    Report Date
    May 25, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K132612
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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: THORACOSCOPIC REPAIR OF IATROGENIC INJURY TO THORACIC AORTA DURING MINIMALLY-INVASIVE ESOPHAGECTOMY: A CASE REPORT AND LITERATURE REVIEW AUTHORS: JINGTING WU A , JEREMY TH TAN B , JACK KIAN CH¿NG A , * CITATION: ANNALS OF VASCULAR SURGERY - BRIEF REPORTS AND INNOVATIONS (2022);2:100092. HTTPS://DOI.(B)(4). THIS CASE REPORT DESCRIBES THE SUCCESSFUL THORACOSCOPIC MANAGEMENT OF AN IATROGENIC THORACIC AORTA INJURY IN MINIMALLY-INVASIVE ESOPHAGECTOMY. A 75-YEAR-OLD MALE WITH LOCALLY ADVANCED SIEWERT TYPE 2 GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA POST NEOADJUVANT CHEMOTHERAPY WAS ELECTIVELY ADMITTED FOR ESOPHAGECTOMY. MINIMALLY-INVASIVE ESOPHAGECTOMY WITH THE MCKEOWN APPROACH WAS PERFORMED BEGINNING IN THE LEFT LATERAL POSITION. REPORTED INTRAOPERATIVE COMPLICATION INCLUDE AN ACCIDENTAL THROUGH-AND-THROUGH PIERCING OF THE LOWER THORACIC AORTA JUST ABOVE THE DIAPHRAGM WITH THE TIP OF A 5 MM ENERGY DEVICE (HARMONIC ACE®7 + SHEARS, JOHNSON & JOHNSON MEDICAL) DURING THE INTRATHORACIC OESOPHAGEAL DISSECTION. THIS OCCURRED WHILE THE PRIMARY SURGEON WAS TRYING TO STOP AN INSTRUMENT FROM FALLING TO THE GROUND. IN CONCLUSION, THORACIC AORTIC INJURY DURING MINIMALLY-INVASIVE ESOPHAGECTOMY IS A RARELY REPORTED BUT HIGHLY FATAL COMPLICATION. AN ATTEMPT AT ACHIEVING CONTROL LAPAROSCOPICALLY MAY BE POSSIBLE IF THE PATIENT MAINTAINS HEMODYNAMIC STABILITY. NEVERTHELESS, IT IS IMPORTANT TO HAVE A LOW THRESHOLD FOR CONVERSION TO OPEN SHOULD THERE BE ANY DOUBTS REGARDING THE PROGRESS OF A THORASCOPIC APPROACH, ESPECIALLY IN INEXPERIENCED HANDS, AS PATIENT SAFETY REMAINS THE UTMOST PRIORITY IN SUCH SITUATIONS. TIMELY CONTROL OF BLEEDING COMBINED WITH TECHNICAL EXPERTISE ALLOWED US TO PERSIST WITH A THORACOSCOPIC APPROACH IN THIS CASE WITH MINIMAL INTRA-OPERATIVE BLOOD LOSS AND HEMODYNAMIC COMPROMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1584466 HARMONIC ACE + 7 INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention