BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9383341 · Received November 27, 2019

    Report

    Report Number
    3005075853-2019-23821
    Event Type
    Injury
    Date Received
    November 27, 2019
    Date of Event
    January 1, 2014
    Report Date
    October 31, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2014. 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.

    Description of Event or Problem · 1

    TITLE: COMPARISON OF PERIOPERATIVE SURGICAL OUTCOMES BETWEEN A BIPOLAR DEVICE AND AN ULTRASONIC DEVICE DURING LAPAROSCOPIC GASTRECTOMY FOR GASTRIC CANCER. AUTHOR: YOU-NA KIM, YOUNG-CHUL YOO, ALI GUNER, IN CHO, IN GYU KWON, YOUN NAM KIM, HOUNG-II KIM. CITATION: SURG ENDOSC (2015) 29:589¿595; DOI 10.1007/S00464-014-3702-8. THIS STUDY AIMED TO RETROSPECTIVELY COMPARE THE PERIOPERATIVE SURGICAL OUTCOMES BETWEEN USING A BIPOLAR DEVICE AND AN ULTRASONIC DEVICE DURING LAPAROSCOPIC GASTRECTOMY. BETWEEN NOV 2010 AND AUG 2013, 186 PATIENTS UNDERWENT LAPAROSCOPIC GASTRECTOMY FOR GASTRIC CANCER USING WITH EITHER BIPOLAR DEVICE (N=116; N=66 MALE AND N=50 FEMALE; MEAN±SD AGE OF 59.9±11.1 YEARS; MEAN BMI OF 23.8±3.5 KG/M^2) OR ULTRASONIC DEVICE (N=70; N=44 MALE AND N=26 FEMALE; MEAN±SD AGE OF 59.3±11.9 YEARS; MEAN BMI OF 23.8±3.4 KG/M^2). IN ULTRASONIC DEVICE GROUP, DISSECTION WAS PERFORMED USING HARMONIC SCALPEL; ETHICON ENDO-SURGERY, CINCINNATI, OH, USA. IN ULTRASONIC DEVICE GROUP (N=70), POSTOPERATIVE VAS SCORE PAIN WERE RECORDED AT 12H (4.7) AND 18H (4.1). OTHER COMPLICATION IN THIS GROUP INCLUDED COLON INJURY (N=1). ANOTHER REASON FOR THE DIFFERENCE IN PAIN WOULD BE ASSOCIATED WITH THE SPREAD OF THERMAL ENERGY TO THE ADJACENT TISSUES INTRAOPERATIVELY. IN A CITED ARTICLE, DURING THE DIVISION OF THYROID GLAND PARENCHYMA IN A PORCINE MODEL, AN ULTRASONIC DEVICE REACHED A HIGHER MAXIMUM TEMPERATURE AND REMAINED ABOVE 60°C FOR A LONGER TIME THAN AN ELECTRONIC VESSEL SEALING DEVICE. COMPARED WITH THE ULTRASONIC DEVICE, THE BIPOLAR DEVICE PROVIDED ADVANTAGES IN OPERATION TIME, DEGREE OF POSTOPERATIVE PAIN, TIME OF DRAIN REMOVAL, AND LENGTH OF HOSPITAL STAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175661 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1