BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX 60 ARTICULATING

    MDR report key: 18334581 · Received December 15, 2023

    Report

    Report Number
    3005075853-2023-09462
    Event Type
    Malfunction
    Date Received
    December 15, 2023
    Date of Event
    March 20, 2023
    Report Date
    December 15, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036001706
    PMA / PMN Number
    K081146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 12/15/2023. 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. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? NO. 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: DIFFERENT APPROACHES OF LAPAROSCOPIC MESOHEPATECTOMY FOR CENTRALLY LOCATED HEPATOCELLULAR CARCINOMAS AUTHOR(S): CHU HONGPENG, MD, WANG GUANNAN, MD, PAN SHANGFEI, MSC, SHEN ZHENGCHAO, MSC, WANG YONGYOU, MSC, AND WANG XIAOMING, MD. CITATION: SURG LAPAROSC ENDOSC PERCUTAN TECH 2023;33:351¿356. THIS STUDY AIMED TO DESCRIBE A SIMPLE AND NOVEL POSITIONAL CLASSIFICATION SYSTEM FOR CENTRALLY LOCATED HEPATOCELLULAR CARCINOMA, BASED ON WHICH DIFFERENT SURGICAL APPROACHES FOR LAPAROSCOPIC MESOHEPATECTOMY WERE CHOSEN. BETWEEN JANUARY 2017 AND DECEMBER 2021, 98 PATIENTS WITH CENTRALLY LOCATED HEPATOCELLULAR CARCINOMA WHO UNDERWENT LAPAROSCOPIC MESOHEPATECTOMY WERE INCLUDED IN THE STUDY. THERE WERE 70 MALES AND 28 FEMALES WITH A MEAN AGE OF 62.1 ±10.4 YEARS (RANGE 39 TO 82). ALL THE PATIENTS UNDERWENT R0 RESECTION. TRANSECTION OF THE PARENCHYMA WAS PERFORMED USING HARMONIC (HARH36, ETHICON ENDO-SURGERY). THE INTRAHEPATIC VESSELS WERE DISSECTED WITH A NON-ETHICON HOM-LOCK AND TITANIUM CLIPS (MANUFACTURERS: UNKNOWN). THE MIDDLE HEPATIC VEIN TRUNK WAS TRANSECTED WITH AN ECHELON FLEX (EC60A, ETHICON ENDO-SURGERY). INTRAOPERATIVE LOCATION AND TRACING WERE PERFORMED USING INTRAOPERATIVE ULTRASOUND AND ICG FLUOROSCOPY. REPORTED COMPLICATIONS INCLUDED INTRAOPERATIVE BLEEDING REQUIRING BLOOD TRANFUSION (N=7), CLAVIEN-DINDO GRADE II PLEURAL EFFUSION COMBINED WITH ASCITES (N=3), AND CLAVIEN-DINDO GRADE IIIA PLEURAL EFFUSION (N=2). IN CONCLUSION, OUR PROPOSED CLASSIFICATION SYSTEM AND CORRESPONDING SURGICAL APPROACH IN LAPAROSCOPIC MESOHEPATECTOMY IS CONDUCIVE TO THE SUCCESSFUL COMPLETION OF SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2268386 FLEX 60 ARTICULATING STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036001706

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown