BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 9661825 · Received February 3, 2020

    Report

    Report Number
    3005075853-2020-00719
    Event Type
    Injury
    Date Received
    February 3, 2020
    Report Date
    January 6, 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 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.

    Description of Event or Problem · 1

    TITLE : IMPACT OF ENERGY DEVICES DURING LIVER PARENCHYMAL. TRANSECTION: A MULTICENTER RANDOMIZED CONTROLLED TRIAL. AUTHOR : NAOTO GOTOHDA ¿ TAKEHARU YAMANAKA ¿ AKIO SAIURA ¿ KATSUHIKO UESAKA ¿ MASAJI HASHIMOTO ¿ MASARU KONISHI ¿ KAZUAKI SHIMADA. CITATION: WORLD J SURG (2015); 39:1543¿1549. DOI 10.1007/S00268-015-2967-Y. THE OBJECTIVE OF THIS STUDY WAS TO CLARIFY THE BENEFIT OF ENERGY DEVICES SUCH AS ULTRASONICALLY ACTIVATED DEVICE AND BIPOLAR VESSEL SEALING DEVICE IN LIVER SURGERIES. THIS PROSPECTIVE MULTICENTER RANDOMIZED STUDY INVOLVES 211 PATIENTS SCHEDULED TO UNDERGO OPEN LIVER RESECTION FOR LIVER TUMOR BETWEEN MAY 2011 AND DECEMBER 2012. THE PATIENTS WERE RANDOMIZED INTO TWO GROUPS: IN EXPERIMENTAL GROUP (GROUP E), 107 PATIENTS (79 MALE; MEDIAN AGE: 63; AGE RANGE: 27-83; MEDIAN BMI: 22.5 KG/M2; BMI RANGE: 16.3-33,2 KG/M2) USED ENERGY DEVICE AND IN CONTROL GROUP (GROUP C), 104 PATIENTS (78 MALE; MEDIAN AGE: 64; AGE RANGE: 30-84; MEDIAN BMI: 22.0 KG/M2; BMI RANGE: 14.9 ¿ 32.6 KG/M2) DID NOT USE AN ENERGY DEVICE. AFTER THE PARENCHYMA WAS CRUSHED, THE EXPOSED VESSEL WERE LIGATED WITH A SILK STRING IN GROUP C, WHILE THE EXPOSED VESSELS WERE SEALED WITH AN ENERGY DEVICE (IF <5 MM, BUT LIGATED WITH A SILK STRING IF >5 MM) IN GROUP E; HARMONIC FOCUS (ETHICON) WAS USED IN 42 PATIENTS AND THE BIPOLAR VESSEL SEALING DEVICE WAS USED IN 65 PATIENTS. REPORTED COMPLICATIONS IN GROUP E INCLUDED SIGNIFICANT INTRAOPERATIVE BLOOD LOSS (N-?), BILE LEAKAGE (N-?), AND POSTOPERATIVE BLEEDING (N-?). IN CONCLUSION, THE USE OF ENERGY DEVICES DURING LIVER SURGERY IS CLINICALLY MEANINGFUL AS IT SHORTENS THE LIVER TRANSECTION TIME AND REDUCES THE INCIDENCE OF POSTOPERATIVE BILE LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123710 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention