BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 12278672 · Received August 4, 2021

    Report

    Report Number
    3005075853-2021-04488
    Event Type
    Injury
    Date Received
    August 4, 2021
    Date of Event
    February 16, 2021
    Report Date
    July 9, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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 IT IS NOT EASY FOR ME TO PROVIDE THE DATA, BECAUSE IT CONTAINS THE PRIVATE INFORMATION OF THE PATIENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). PUBLICATION YEAR OF 2021. BATCH # UNK. (B)(4). 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. DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN.

    Description of Event or Problem · 1

    TITLE: IS IT BENEFICIAL TO UTILIZE AN ARTICULATING INSTRUMENT IN SINGLE-PORT LAPAROSCOPIC GASTRECTOMY? AUTHOR/S: AMY KIM, CHANG MIN LEE, SUNGSOO PARK CITATION: J GASTRIC CANCER. 2021 MAR;21(1):38-48 HTTPS://DOI.ORG/10.5230/JGC.2021.21.E2 PISSN 2093-582X·EISSN 2093-5641. THIS STUDY AIMED TO EVALUATE THE FEASIBILITY OF THIS NEW DEVICE DURING SINGLE-PORT LAPAROSCOPIC DISTAL GASTRECTOMY (SP-LDG) FOR EARLY GASTRIC CANCER (EGC) PATIENTS. A TOTALOF 17 PATIENTS DIAGNOSED WITH EGC WHO UNDERWENT SP-LDG WITH ARTISENTIAL® (LIVSMED) GRASPERS BETWEEN APRIL 2018 AND AUGUST 2020 WERE INCLUDED. THE CLINICAL OUTCOMES WERE COMPARED WITH THOSE OF A CONTROL GROUP, IN WHICH PREBENT GRASPERS (OLYMPUS MEDICAL SYSTEMS CORP) WERE USED FOR THE SAME PROCEDURES. THE FOLLOWING PATIENTS WERE CONSIDERED ELIGIBLE: 1) THOSE WHO WERE TREATED WITH SP-LDG WITH D1+ OR D2 DISSECTION FOR HISTOLOGICALLY PROVEN GASTRIC ADENOCARCINOMA WITH A CURATIVE INTENT, 2) THOSE BETWEEN 20 AND 80 YEARS OF AGE, 3) THOSE WITH CLINICAL STAGE IA (CT1N0M0) DISEASE BASED ON THE FINDINGS OF ESOPHAGOGASTRODUODENOSCOPY AND ABDOMINAL COMPUTED TOMOGRAPHY, AND 4) THOSE WITH AN AMERICAN SOCIETY OF ANESTHESIOLOGY (ASA) SCORE OF I, II, OR III. HAMONIC ACE 7 (ETHICON ENDO-SURGERY INC., CINCINNATI, OH, USA) WAS USED TO FACILITATE D1+ OR D2 LYMPHADENECTOMY IN ALL PATIENTS. AFTER THE COMPLETION OF LYMPHADENECTOMY, BILLROTH I OR II ANASTOMOSIS WAS PERFORMED FOR THE RECOVERY OF GASTROINTESTINAL CONTINUITY. ALL GASTROINTESTINAL RESECTIONS AND ANASTOMOSES WERE PERFORMED WITH AN ECHELON FLEX¿ POWERED ENDOPATH® STAPLER (ETHICON ENDO-SURGERY INC., CINCINNATI, OH, USA). THE DETAILED CLINICOPATHOLOGIC OUTCOMES OF THE ENROLLED PATIENTS AND THE POSTOPERATIVE COMPLICATIONS IN THE ARTISENTIAL® GROUP WERE ANALYZED ACCORDING TO THE CDC. THERE WAS NO SIGNIFICANT DIFFERENCE IN THE TOTAL OPERATIVE TIME (218.1±9.9 VS. 205.4±6.0 MINUTES, P=0.270) OR TIME SPENT FOR LND (60.6±5.5 VS. 52.7±1.8, P=0.473) BETWEEN THE TWO GROUPS. IN ADDITION, THE GROUPS EXHIBITED SIMILAR RATES OF EARLY (35.3% VS. 36.0%, P=0.613) AND LATE COMPLICATIONS (5.9% VS. 4.0%, P=0.652), AND THERE WAS NO SIGNIFICANT DIFFERENCE IN MORBIDITY RATE (5.9% VS.16.0%, P=0.315). REPORTED COMPLICATIONS ICLUDED N=2 INTRAABDOMINAL ABSCESS (CDC GRADE IIIA), N=1 UNIDENTIFIED FEVER AND LEUKOCYTOSIS (CDC GRADE II) ON 4TH POSTOP DAY AND N=1 PARALYTIC ILEUS. IN CONCLUSION, THE NEW MULTI-DOF ARTICULATING GRASPER IS FEASIBLE AND CAN BE USED AS AN ALTERNATIVE FOR PREBENT GRASPERS DURING SINGLE-PORT LAPAROSCOPIC GASTRECTOMY (SP-LDG).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1174859 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention