BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSEAL GENERIC PRODUCT CODE

    MDR report key: 10001118 · Received April 27, 2020

    Report

    Report Number
    3005075853-2020-02351
    Event Type
    Injury
    Date Received
    April 27, 2020
    Report Date
    March 30, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K072177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 04/27/2020. DATE OF EVENT: UNKNOWN. BATCH # UNKNOWN. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: THE IMMEDIATE RESULTS OF APPLYING VARIOUS WAYS OF FORMING ILEOTRANSVERSE ANASTOMOSIS IN RIGHT HEMICOLECTOMY IN ONCOLOGY PRACTICE AUTHORS: GLUSHKOV E.A., NIKITIN N.A., IVANOV A.D., KISLICHKO S.A. CITATION: VYATKA MEDICAL HERALD, NO. 3 (63), 2019: 22-26. DOI: 10.24411/2220-7880-2019-10005. THE OBJECTIVE OF THIS STUDY WAS TO INTRODUCE THE INVAGINATION ILEOTRANSVERSE ANASTOMOSIS (ITA) PROPOSED BY NIKITIN INTO THE PRACTICE OF PERFORMING RIGHT-SIDED HEMICOLECTOMY IN PLANNED ONCOLOGY AND TO STUDY THE IMMEDIATE RESULTS OF ITS USE AS COMPARED TO AN END-TO-SIDE TRANSVERSE ITA AND A LONGITUDINAL LATERAL ITA. THE STUDY INCLUDED 73 PATIENTS (AGE RANGE:43 TO 83 YEARS) WITH CONFIRMED ADENOCARCINOMA OF THE RIGHT HALF OF THE COLON IN STAGES I-IV, WHO UNDERWENT TREATMENT OVER THE PERIOD EXTENDING FROM 2017 THROUGH 2018 AND WHO WERE REPRESENTED BY THREE GROUPS AS A FUNCTION OF THE ITA FORMATION METHOD USED: NIKITIN'S ITA GROUP INCLUDED 22 OBSERVATIONS (10 MALE AND 12 FEMALE; AGE: 67±8.6 YEARS; BMI: 23.2±4.4 KG/CM2); TRANS-VERSE END-TO-SIDE ITA GROUP INCLUDED 21 OBSERVATIONS (13 MALE AND 8 FEMALE; AGE: 64±7.6 YEARS; BMI: 26.7±4.8 KG/CM2); AND LONGITUDINAL LATERAL ITA GROUP INCLUDED 30 OBSERVATIONS (17 MALE AND 13 FEMALE; AGE: 65±9.4 YEARS; BMI: 25.9±5.1 KG/CM2). DURING THE PROCEDURE, THE SURGICAL RELEASE OF THE RIGHT HALF OF THE COLON AND LYMPHODISSECTION WERE CARRIED OUT USING THE ENSEAL TECHNOLOGY (ENSEAL, BIPOLAR; ETHICON). AN NTLC 75 LINEAR CUTTER (ETHICON) WAS USED DURING INTESTINE TRANSECTION. REPORTED COMPLICATION IN THE NIKITIN'S ITA GROUP INCLUDED IN THE PAIN SYNDROME (N-?). REPORTED COMPLICATION IN THE TRANS-VERSE END-TO-SIDE ITA GROUP INCLUDED IN THE PAIN SYNDROME (N-?). REPORTED COMPLICATIONS IN THE LONGITUDINAL LATERAL ITA GROUP INCLUDED IN THE PAIN SYNDROME (N-?) AND BLEEDING (N-1) IN WHICH THE PATIENT REQUIRED A SECOND SURGICAL INTERVENTION. THE BEST RESULTS WERE OBTAINED IN PATIENTS WITH INVAGINATIONAL ITA ACCORDING TO NIKITIN, THE WORST IN PATIENTS WITH LONGITUDINAL ITA SIDE TO SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465779 ENSEAL GENERIC PRODUCT CODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention