BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSEAL GENERIC PRODUCT CODE

    MDR report key: 15490372 · Received September 27, 2022

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    Report

    Report Number
    3005075853-2022-06434
    Event Type
    Injury
    Date Received
    September 27, 2022
    Date of Event
    January 1, 2020
    Report Date
    September 26, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K072177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE OF EVENT: 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 THERE WERE ANY ETHICON DEVICE DEFICIENCIES THAT CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS AND/OR THE PATIENT DEATHS? WOULD THE AUTHOR/SURGEON BE INTERESTED IN SPEAKING WITH ETHICON MEDICAL AND ENGINEERING TEAM REGARDING THIS EVENT? 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: LIVER RESECTIONS IN CHILDREN: TIPS, TRICKS AND OVERCOMING THE INITIAL LEARNING CURVE. AUTHORS: PETERS N., SAMUJH R., MALIK M., YADDANAPUDI S., SAXENA A. CITATION CITE: PEDIATRIC BLOOD AND CANCER. 2020 DEC. RETROSPECTIVELY EVALUATED THE DATA OF CONSECUTIVE 9 PATIENTS WHO UNDERWENT PLR OVER A PERIOD OF 21/2 YEARS (JANUARY 2017 TO JUNE 2019). ALL PATIENTS UNDERWENT ULTRASOUND ABDOMEN, TRIPLE PHASE CECT ABDOMEN AND CT SCAN CHEST. AVERAGE AGE WAS 19 MONTHS. PARENCHYMAL RESECTION WAS CARRIED OUT USING HARMONIC SCALPEL (ETHICON) AND ENSEAL (ETHICON) IN ALL CASES. REPORTED COMPLICATIONS INCLUDED POST-OPERATIVE BILE LEAK (N=1), ONE PATIENT SUCCUMBED ON TABLE WITH SUSPECTED AIR EMBOLISM. IN CONCLUSION PLR IS A TECHNICALLY CHALLENGING SURGERY. AN EXHAUSTIVE PRE-OPERATIVE WORK UP, METICULOUS INTRAOPERATIVE STEPS AND DYNAMIC INTERACTION WITH ANAESTHESIOLOGISTS AND RADIOLOGISTS AND ADVANCED ENERGY SOURCES AID IN SAFE RESECTIONS. NEGATIVE MARGINS ARE ACHIEVABLE IN MOST SITUATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2302961 ENSEAL GENERIC PRODUCT CODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention