BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSEAL G2 SUPER JAW

    MDR report key: 10561100 · Received September 21, 2020

    Report

    Report Number
    3005075853-2020-04776
    Event Type
    Injury
    Date Received
    September 21, 2020
    Report Date
    August 25, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    UDI-DI
    10705036013808
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. PLEASE CONFIRM WHICH DEVICE (ULTRACISION OR ENSEAL G2 TISSUE SEALER) WAS USED IN PATIENTS WHO EXPERIENCED BLEEDING OF THE IVC, BILIARY LEAKAGE, AND INTRA-ABDOMINAL ABSCESS. DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. 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 · 1

    TITLE: A MULTICENTER COHORT ANALYSIS OF LAPAROSCOPIC HEPATIC CAUDATE LOBE RESECTION AUTHOR(S): M. CAPPELLE & D. L. AGHAYAN & M. J. VAN DER POEL & M. G. BESSELINK & G. SERGEANT & B. EDWIN & I. PARMENTIER & C. DE MEYERE & F. VANSTEENKISTE & M. D¿HONDT CITATION: LANGENBECK'S ARCHIVES OF SURGERY (2020) 405:181¿189; DOI: HTTPS://DOI.ORG/10.1007/S00423-020-01867-2. THIS MULTICENTER RETROSPECTIVE COHORT STUDY AIMED TO REPORT ON OUTCOMES, CLARIFY TECHNICAL ASPECTS, AND ANALYZE INTERINSTITUTIONAL DIFFERENCES OF LAPAROSCOPIC RESECTION OF THE CAUDATE LOBE (LRCL). BETWEEN JAN200 AND MAY2018, 32 PATIENTS (N=20 MALE; MEDIAN AGE OF 61 YEARS) WITH COLORECTAL METASTASIS (N=22), OTHER (N=4), CHOLANGIOCARCINOMA (N=1), AND BENIGN DISEASE (N=5) UNDERWENT LAPAROSCOPIC HEPATIC CAUDATE LOBE RESECTION. IN THE PROCEDURE, THE SUPERFICIAL HEPATIC PARENCHYMA IS TRANSECTED USING AN ULTRASONIC SCALPEL (ULTRACISION, ETHICON ENDO-SURGERY INC., CINCINATTI, OH, USA) OR BIPOLAR SEALING DEVICE (ENSEAL G2 TISSUE SEALER, ETHICON ENDO-SURGERY INC., CINCINNATI, OH, USA). ONE PATIENT WAS CONVERTED TO OPEN APPROACH WHEN A BLEEDING OF THE INFERIOR VENA CAVA (IVC) WAS ENCOUNTERED. POSTOPERATIVE COMPLICATIONS INCLUDED INTRAABDOMINAL ABSCESS TREATED WITH PERCUTANEOUS DRAINAGE AND BILIARY LEAKAGE TREATED WITH ENDOSCOPIC STENTING. BOTH PATIENTS REQUIRED READMISSION WITHOUT THE NEED OF SURGICAL INTERVENTION. THE MOST COMMON REASON FOR CONVERSION IN LLR IS BLEEDING, EITHER OF THE IVC, MAJOR HEPATIC VEINS, SHORT VEINS, OR PORTAL TRIADS AS REPORTED BY OTHERS. INCREASING THE PNEUMOPERITONEUM PRESSURE AND DECREASING THE AIRWAY PRESSURE CAN BE USED TO DECREASE BACK-BLEEDING AND CONTROL THE BLEEDING BY BIPOLAR COAGULATION OR AN INTRACORPOREAL SUTURE. BECAUSE OF THE CLOSE RELATIONSHIP OF THE CAUDATE LOBE TO THE HEPATIC HILUM, THE MAJOR HEPATIC VEINS AND THE IVC MASSIVE HEMORRHAGE ARE THE MOST FEARED COMPLICATIONS DURING LAPAROSCOPIC RESECTION. LAPAROSCOPIC RESECTION OF THE HEPATIC CAUDATE LOBE IS TECHNICALLY CHALLENGING DUE TO ITS DEEP ANATOMICAL LOCATION AND CLOSE RELATIONSHIP WITH THE CAVAL VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028230 ENSEAL G2 SUPER JAW ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. NSEALX22L 10705036013808

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention