BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9532748 · Received December 30, 2019

    Report

    Report Number
    3005075853-2019-24838
    Event Type
    Injury
    Date Received
    December 30, 2019
    Date of Event
    January 1, 2001
    Report Date
    December 5, 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 2001. 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: HEPATECTOMY USING THE COAGULATING SHEARS TYPE OF ULTRASONICALLY ACTIVATED SCALPEL. AUTHOR/S: T. OKAMOTO Y. NAKASATO S. YANAGISAWA H. KASHIWAGI Y. YAMAZAKI T. AOKI, CITATION: DIG SURG 2001; 18:427¿430. THE PURPOSE OF THIS STUDY WAS TO DISCUSS THE NOTEWORTHY POINTS AND PROBLEMS OF USE, AND SHOWS THE INITIAL RESULTS WITH REGARD TO THE USEFULNESS AND SAFETY OF THE ULTRASONICALLY ACTIVATED SCALPEL (UAS) APPARATUS, ESPECIALLY THE CS TYPE. FROM 1995 TO 1999, A TOTAL OF 30 PATIENTS UNDERWENT HEPATECTOMIES WITH A UAS. THE ULTRASOUND EQUIPMENT EMPLOYED WAS THE HARMONIC SCALPEL (ETHICON). THREE TYPES OF UAS BLADE TIPS ARE AVAILABLE FOR THIS DEVICE: THE HOOK TYPE, THE BALL-COAGULATOR TYPE, AND THE FORCEPS-LIKE CS TYPE, ALL OF WHICH EFFECT BOTH CUTTING AND COAGULATION WHEN THE BLADE IS APPLIED DIRECTLY TO LIVING TISSUE. THE CS TYPE WAS USED IN THIS STUDY. THE PORTA HEPATIS WAS DISSECTED, THE RIGHT LOBE WAS MOBILIZED. TRACTION SUTURES WERE ATTACHED TO THE PORTION OF PARENCHYMA TO BE REMOVED AND, KEEPING AN APPROPRIATE DEGREE OF TENSION ON THE LINE OF DIVISION BY GRASPING THE PARENCHYMA TO BE LEFT, THE INCISION PROCESS IS BEGUN ON THE SURFACE LAYERS OF THE LIVER AT THE POWER LEVEL OF 3, WITH THE BLADE IN THE BLUNT MODE AND AN EXECUTION TIME OF APPROXIMATELY 5¿10 S. POSTOPERATIVE COMPLICATIONS INCLUDED POSITIVE BILE LEAKAGE TEST (N=8); POSTOPERATIVE BILE FISTULAS (N=3); AND BLOOD LOSS (N=?). ALTHOUGH A DRAMATIC IMPROVEMENT IN BLOOD LOSS AND OPERATING TIME COULD NOT BE OBTAINED IN ALL TYPES OF HEPATECTOMIES, THE SAFETY AND USEFULNESS WERE DEMONSTRATED IN ALL PROCEDURES. THE UAS CAN BE CONSIDERED AS A SURGICAL DEVICE THAT CAN CONTRIBUTE TO THE EFFICIENCY OF HEPATECTOMY, DEPENDING ON THE INDICATIONS SELECTED, AND STUDY OF THE EFFECTS ON THE BILE DUCT IS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1323570 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1