BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9529809 · Received December 30, 2019

    Report

    Report Number
    3005075853-2019-24800
    Event Type
    Injury
    Date Received
    December 30, 2019
    Date of Event
    January 1, 2000
    Report Date
    December 4, 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 · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2000. MEDICAL DEVICE: BATCH # UNK. THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ENTITLED: INITIAL EXPERIENCE WITH THE HARMONIC SCALPEL IN LIVER SURGERY. AUTHOR : P. GERTSCH, A.PELLONI, A GUERRA, A KRPO. CITATION: HEPATO-GASTROENTEROLOGY 2000; 47: 763-766. THE PURPOSE OF THIS PROSPECTIVE STUDY WAS TO DISCUSS THE POTENTIAL OF HARMONIC SCALPEL IN LIVER SURGERY. A TOTAL OF 16 PATIENTS [N=9 MALE, N=7 FEMALE, MEDIAN AGE 64 YEARS (RANGE 31-79 YEARS)] UNDERWENT LIVER SURGERY. THE LIVER PARENCHYMA WAS CUT WITH HARMONIC SCALPEL (ULTRACISION, ETHICON-ENDOSURGERY). THE SECTION OF THE LIVER PARENCHYMA WAS PERFORMED USING EITHER THE SHARP EDGE OF THE BLADE FOR CUTTING GLISSON¿S CAPSULE OR SMALL INTRA-HEPATIC VESSELS, OR ITS BLUNT EDGE OR FLAT SIDE TO PROGRESS INTO THE SECTION OF LIVER PARENCHYMA BY FORWARD PROGRESSION WITH SMALL HORIZONTAL MOVEMENTS. VESSELS WERE SEALED BY APPLYING THE BLUNT EDGE OF THE BLADE BEFORE SECTION. THIS REPORT REPRESENTS A (B)(6)-YEAR OLD MALE THAT HAD BILIARY FISTULA WHICH HEALED SPONTANEOUSLY WITHIN 12 DAYS AFTER PERCUTANEOUS DRAINAGE; AND HAD BLOOD LOSS OF 700 ML WHICH REQUIRED TRANSFUSION OF 3 UNITS PRC. THE HARMONIC SCALPEL ALLOWS EFFICIENT SECTION OF LIVER PARENCHYMA, PRECISE DISSECTION OF INTRAHEPATIC STRUCTURES, GOOD HEMOSTATICS AND SECTION OF SMALL INTRAHEPATIC VESSELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1324874 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention