BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 9652754 · Received January 31, 2020

    Report

    Report Number
    3005075853-2020-00645
    Event Type
    Injury
    Date Received
    January 31, 2020
    Report Date
    January 3, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2018. 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.

    Description of Event or Problem · 1

    TITLE : A NOVEL LIVER RETRACTION METHOD IN LAPAROSCOPIC GASTRECTOMY FOR GASTRIC CANCER. AUTHOR : YUKI USHIMARU · TAKESHI OMORI · YOSHIYUKI FUJIWARA · YUJI SHISHIDO · YOSHITOMO YANAGIMOTO ·KEIJIROU SUGIMURA · KAZUYOSHI YAMAMOTO· JEONG-HO MOON· HIROSHI MIYATA· MASAYUKI OHUE· MASAHIKO YANO. CITATION: SURGICAL ENDOSCOPY (2019) 33:1828¿1836; HTTPS://DOI.ORG/10.1007/S00464-018-6461-0. THIS RETROSPECTIVE STUDY DISCUSSED ABOUT A NOVEL LIVER RETRACTION METHOD IN LAPAROSCOPIC GASTRECTOMY FOR GASTRIC CANCER. BETWEEN JANUARY 2012 AND DECEMBER 2016, 106 PATIENTS WHO HAD UNDERGONE LAPAROSCOPIC DISTAL GASTRECTOMY (LDG) FOR EARLY GASTRIC CANCER WERE INCLUDED IN THE STUDY, 53 PATIENTS (MALE=40, FEMALE=13; MEAN AGE=67 YEARS, AGE RANGE=34 ¿ 79 YEARS; MEAN BMI= 22.6 KG/M^2, BMI RANGE=15.7 ¿ 29.5 KG/M^2) IN THE FLEXIBLE LIVER RETRACTION WITH CLIPPING AND SUTURING (FLICS) GROUP AND 53 PATIENTS (MALE=41, FEMALE=12; MEAN AGE=66 YEARS, AGE RANGE=27 ¿ 91 YEARS; MEAN BMI= 22.1 KG/M^2, BMI RANGE=17.7 ¿ 29.5 KG/M^2)IN THE NATHANSON RETRACTOR (NR) GROUP. DURING THE PROCEDURE, A CONVENTIONAL STRAIGHT GRASPER AND ULTRASONIC COAGULATION CUTTING DEVICE (HARMONIC SCALPEL; ETHICON) WAS USED TO PERFORM GASTRIC MOBILIZATION AND LYMPH NODE DISSECTION. REPORTED COMPLICATIONS IN FLICS GROUP INCLUDED CHYLOPERITONEUM (N=1). REPORTED COMPLICATIONS IN NR GROUP INCLUDED CHYLOPERITONEUM (N=1); ANASTOMOTIC LEAKAGE (N=1) WHICH REQUIRED REOPERATION. IN CONCLUSION, NEW LIVER RETRACTION TECHNIQUE PROVIDED AN OPTIMAL SURGICAL FIELD WITHOUT INDUCING LIVER DYSFUNCTION. IT IS A SIMPLE, SAFE, AND EFFECTIVE LIVER RETRACTION TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118359 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention