BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSEAL GENERIC PRODUCT CODE

    MDR report key: 15563317 · Received October 7, 2022

    Report

    Report Number
    3005075853-2022-06304
    Event Type
    Injury
    Date Received
    October 7, 2022
    Date of Event
    January 1, 2021
    Report Date
    September 21, 2022
    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). PUBLICATION YEAR OF 2021. 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: FEASIBILITY AND SAFETY OF TOTAL LAPAROSCOPIC RETROGRADE HYSTERECTOMY IN A LARGE UTERUS WITH OBLITERATED CUL-DE-SAC DUE TO SEVERE ENDOMETRIOSIS AUTHORS: MEGUMI YAMAMOTO A,B, HIROSHI YOSHIDA A,C,* CITATION: EUROPEAN JOURNAL OF OBSTETRICS & GYNECOLOGY AND REPRODUCTIVE BIOLOGY (2021); 258:43¿47. HTTPS://DOI.ORG/10.1016/J.EJOGRB.2020.12.042. THE AIM OF THIS SINGLE-INSTITUTE, RETROSPECTIVE, CASE-CONTROL, OBSERVATIONAL STUDY IS TO EXAMINE THE SAFETY AND FEASIBILITY OF TOTAL LAPAROSCOPIC RETROGRADE HYSTERECTOMY (TLREH) IN PATIENTS WITH OBLITERATED CUL-DE-SAC DUE TO SEVERE ENDOMETRIOSIS, INCLUDING PATIENTS WITH A LARGE UTERUS. BETWEEN JANUARY 2014 AND DECEMBER 2019, A TOTAL OF 92 WOMEN (MEAN AGE OF 46.0 ± 4.8 YEARS; MEAN BMI OF 22.2 [17.0¿42.0] KG/M2) WITH OBLITERATED CUL-DE-SAC DUE TO SEVERE ENDOMETRIOSIS WHO UNDERWENT TLREH WERE INCLUDED. THE ENERGY DEVICE USED WAS THE ENSEAL (JOHNSON AND JOHNSON K.K. MEDICAL COMPANY, TOKYO, JAPAN). REPORTED COMPLICATIONS INCLUDE UNKNOWN EVENT REQUIRING BLOOD TRANSFUSION (N=1) AND BLADDER INJURY (N=1). IN CONCLUSION, THE STUDY DEMONSTRATED THAT TLREH FOR SEVERE ENDOMETRIOSIS WITH OBLITERATED CUL-DE-SAC WAS FEASIBLE AND SAFE. IT COULD BE SAFELY PERFORMED FOR LARGE UTERI (=600 G) WITH OBLITERATED CUL-DE-SAC DUE TO SEVERE ENDOMETRIOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1077125 ENSEAL GENERIC PRODUCT CODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention