BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9379961 · Received November 26, 2019

    Report

    Report Number
    3005075853-2019-23791
    Event Type
    Injury
    Date Received
    November 26, 2019
    Date of Event
    January 1, 2015
    Report Date
    October 28, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: NO FURTHER INFORMATION WILL BE PROVIDED, BECAUSE WE CAN'T GET ANY ADDITIONAL INFORMATION FROM THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2015. 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. DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. (B)(4).

    Description of Event or Problem · 1

    TITLE: A RANDOMIZED PHASE II STUDY OF THE CLINICAL EFFECTS OF ULTRASONICALLY ACTIVATED COAGULATING SHEARS (HARMONIC SCALPEL) IN OPEN GASTRECTOMY FOR GASTRIC CANCER. AUTHORS: RYOHEI KAWABATA, · SHUJI TAKIGUCHI · YUTAKA KIMURA · HIROSHI IMAMURA · JUNYA FUJITA · SHIGEYUKI TAMURA · KAZUMASA FUJITANI · KENTARO KISHI · KAZUYOSHI YAMAMOTO · SHINICHI FUJIWARA · YUKINORI KUROKAWA · MASAKI MORI · YUICHIRO DOKI CITATION: SURG TODAY (2016) 46:561¿568 / DOI 10.1007/S00595-015-1213-4. THE PURPOSE OF THIS MULTI-INSTITUTIONAL, PROSPECTIVE, RANDOMIZED, CONTROLLED TRIAL WAS TO EVALUATE THE UTILITY AND EFFICACY OF THE HARMONIC SCALPEL IN OPEN RADICAL GASTRECTOMY IN GASTRIC CANCER PATIENTS. BETWEEN APR 2010 AND NOV 2011, A TOTAL OF 237 PATIENTS UNDERWENT RADICAL TOTAL GASTRECTOMY OR DISTAL SUBTOTAL GASTRECTOMY FOR GASTRIC CANCER TREATMENT. THE PATIENTS WERE RANDOMLY ASSIGNED TO RECEIVE EITHER GASTRECTOMY USING CONVENTIONAL MONOPOLAR ELECTROCAUTERY AND SUTURE LIGATION (CONVENTIONAL GROUP) [N=114, (N=75 MALE, N=39 FEMALE, MEAN AGE 67 ± 11 YEARS, BMI 21.8 ± 3.1 KG/M2)] OR HARMONIC SCALPEL (HARMONIC GROUP) [N=123, (N=79 MALE, N=44 FEMALE, MEAN AGE 67 ± 11 YEARS, BMI 22.3 ± 3.0 KG/M2)]. IN THE HARMONIC GROUP, SURGEONS USED THE HARMONIC SCALPEL (ETHICON) FOR HEMOSTASIS AND TISSUE DISSECTION AS MUCH AS POSSIBLE INSTEAD OF THE CONVENTIONAL METHODS. POSTOPERATIVE COMPLICATIONS INCLUDED BLEEDING (N=1), ANASTOMOTIC LEAKAGE (N=4), ABDOMINAL ABSCESS (N=4), BOWEL OBSTRUCTION (N=1), ANASTOMOTIC STENOSIS (N=2), INJURY TO THE GALLBLADDER (N=1) WHEREIN REOPERATION WAS PERFORMED, AND OTHERS (N=8). THE HARMONIC SCALPEL PROCEDURE WAS NOT SUPERIOR TO THE CONVENTIONAL MONOPOLAR ELECTROSURGERY WITH REGARD TO REDUCING THE LENGTH OF THE OPERATION, BLOOD LOSS, POSTOPERATIVE COMPLICATIONS, OR POSTOPERATIVE HOSPITAL STAY IN RADICAL OPEN GASTRECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1174278 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE