BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSEAL GENERIC PRODUCT CODE

    MDR report key: 15457756 · Received September 20, 2022

    Report

    Report Number
    3005075853-2022-06275
    Event Type
    Injury
    Date Received
    September 20, 2022
    Date of Event
    October 16, 2021
    Report Date
    September 20, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K072177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH # UNK. THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY 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

    IT WAS REPORTED THAT DURING A JOURNAL ARTICLE: TITLE: BIPOLAR VESSEL SEALING SYSTEM VERSUS SILK LIGATION OF LYMPHATIC VESSELS IN RENAL TRANSPLANT RECIPIENT LYMPHATIC COMPLICATIONS: A RANDOMIZED CONTROLLED TRIAL. AUTHORS: PREM RAJ SIGDEL1 · DIWAS GNYAWALI1 · JEEVAN THAPA2 · BIPENDRA D. K. RAI1 · PAWAN DHITAL1 · PURUSHOTTAM PARAJULI1 · SAMPANNA CHUDAL1 · MANISH PRADHAN1 · SUJEET POUDYAL1 · SUMAN CHAPAGAIN1 · BHOJ R. LUITEL1 · PAWAN R. CHALISE1 · PREM R. GYAWALI1 · UTTAM K. SHARMA1 CITATION: INTERNATIONAL UROLOGY AND NEPHROLOGY (2021); 53:2477¿2483. HTTPS://DOI.ORG/10.1007/S11255-021-03003-5. THE AIM OF THIS PROSPECTIVE SINGLE-CENTRE, RANDOMIZED CONTROLLED STUDY WAS TO COMPARE LYMPHATIC COMPLICATIONS OF BIPOLAR VESSEL SEALING SYSTEM WITH SILK LIGATION OF LYMPHATIC VESSELS AMONG RENAL TRANSPLANT RECIPIENTS. BETWEEN APRIL 2019 TO MARCH 2020, ALL PATIENTS UNDERGOING RENAL TRANSPLANTATION IN TUTH AND CONSENTING FOR PARTICIPATION WERE INCLUDED FOR THE STUDY. TOTAL OF 68 CASES WERE RANDOMISED FOR THE STUDY (FIG. 1). AFTER EXCLUSION OF 10 CASES, 58 CASES WERE ANALYSED, 28 PATIENTS (24 MALE AND 4 FEMALE; MEAN AGE OF 33.50 ± 11.18 YEARS) IN BIPOLAR VESSEL SEALING SYSTEM AND 30 CASES (27 MALE AND 3 FEMALE; MEAN AGE OF 33.83 ± 10.31 YEARS) IN SILK GROUP. THE LYMPHATIC TISSUES OVERLYING THE VESSELS WERE LIGATED WITH A SILK 3.0 TIE IN THE SILK GROUP. IN THE BIPOLAR VESSEL SEALING SYSTEM GROUP, ENSEAL® G2 STRAIGHT TISSUE SEALER WAS USED. THE GENERATOR USED FOR THIS SYSTEM WAS ETHICON ENDO-SURGERY GENERATOR (GEN-11). REPORTED COMPLICATIONS INCLUDE UNKNOWN EVENT REQUIRING RE-EXPLORATION (N=2), SIGNIFICANT LYMPHORRHEA (N=6), AND SYMPTOMATIC LYMPHOCELE (N=2). IN CONCLUSION, THIS STUDY DID NOT FIND ANY SIGNIFICANT DIFFERENCES IN LYMPHATIC COMPLICATIONS BETWEEN BIPOLAR VESSEL SEALING SYSTEM AND SILK LIGATION. HOWEVER, LARGE SAMPLE MULTI-CENTRIC STUDIES SHOULD BE DONE TO ADD EVIDENCES ON LYMPHATIC COMPLICATIONS DIFFERENCES BETWEEN THESE TWO TECHNIQUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2694886 ENSEAL GENERIC PRODUCT CODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention GENERATOR.