BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSEAL GENERIC PRODUCT CODE

    MDR report key: 17172457 · Received June 21, 2023

    Report

    Report Number
    3005075853-2023-04343
    Event Type
    Injury
    Date Received
    June 21, 2023
    Date of Event
    October 1, 2022
    Report Date
    June 21, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K072177
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 6/21/2023. 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. 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? IF YES, PLEASE EXPLAIN NO FURTHER INFORMATION WILL BE PROVIDED BECAUSE WE CAN¿T GET ANY ADDITIONAL INFORMATION FROM THE AUTHOR. 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: AN ADVANCED BIPOLAR DEVICE HELPS REDUCE THE RATE OF POSTOPERATIVE PANCREATIC FISTULA IN LAPAROSCOPIC GASTRECTOMY FOR GASTRIC CANCER PATIENTS: A PROPENSITY SCORE-MATCHED ANALYSIS. AUTHORS: KAZUNORI SHIBAO1 · SHINSAKU HONDA1 · YASUHIRO ADACHI1 · SHIRO KOHI1 · YUZAN KUDOU1 · NOBUTAKA MATAYOSHI1 · NAGAHIRO SATO1 · KEIJI HIRATA1 CITATION: LANGENBECK'S ARCHIVES OF SURGERY (2022); 407:3479¿3486. HTTPS://DOI.ORG/10.1007/S00423-022-02692-5. THE AIM OF THIS RETROSPECTIVE COHORT STUDY WAS TO COMPARE THE EFFICACY AND SAFETY OF ABD AND USAD IN LAPAROSCOPIC GASTRECTOMY FOR GASTRIC CANCER PATIENTS. BETWEEN AUGUST 2008 AND SEPTEMBER 2020, A TOTAL OF 371 PATIENTS WHO UNDERWENT LAPAROSCOPIC DISTAL GASTRECTOMY (LDG) WITH LYMPH NODE DISSECTION WERE INCLUDED IN THE STUDY. LDG WAS PERFORMED USING AN ABD (LIGASURE¿; MEDTRONIC PLC, DUBLIN, IRELAND, OR ENSEAL®; ETHICON ENDO-SURGERY, CINCINNATI, OH, USA) IN 169 PATIENTS (109 MALE AND 60 FEMALE; MEDIAN AGE OF 71 (35¿90) YEARS; MEDIAN BMI OF 22 (14.2¿45) KG/M2) OR USAD (HARMONIC®; ETHICON ENDO-SURGERY OR SONICISION¿; MEDTRONIC PLC) IN 202 PATIENTS (123 MALE AND 79 FEMALE; MEDIAN AGE OF 70 (33¿97) YEARS; MEDIAN BMI OF 23 (14.4¿35.8) KG/M2) AS THE MAIN ENERGY DEVICE FOR DISSECTION, AT EACH SURGEON¿S PREFERENCE. REPORTED COMPLICATIONS INCLUDE 90-DAY MORTALITY (N=?), POPF GRADE B AND C (N=?), INTRAABDOMINAL ABSCESS (N=?), ANASTOMOTIC LEAKAGE (N=?), ANASTOMOTIC STRICTURE (N=?), LYMPHOLEA (N=?), SMALL BOWEL OBSTRUCTION (N=?), ILEUS (N=?), AND OTHER COMPLICATIONS (N=?). IN CONCLUSION, AN ABD MAY IMPROVE THE SAFETY OF LAPAROSCOPIC GASTRECTOMY FOR GASTRIC CANCER PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207100 ENSEAL GENERIC PRODUCT CODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention GENERATOR