BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9470621 · Received December 14, 2019

    Report

    Report Number
    3005075853-2019-24330
    Event Type
    Injury
    Date Received
    December 14, 2019
    Report Date
    November 18, 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 2012. 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 : SURGICAL OUTCOME OF LIVER TRANSECTION BY THE CRUSH-CLAMPING TECHNIQUE COMBINED WITH HARMONIC FOCUSTM AUTHOR : NAOTO GOTOHDA ¿ MASARU KONISHI ¿ SHINICHIRO TAKAHASHI ¿ TAKAHIRO KINOSHITA ¿ YUICHIRO KATO ¿ TAIRA KINOSHITA. CITATION: WORLD J SURG (2012) 36:2156¿2160; DOI 10.1007/S00268-012-1624-Y. THIS STUDY AIMED TO EVALUATE OUTCOMES OF HEPATECTOMY USING HARMONIC FOCUS (HF) AND HARMONIC ACE (HA). FROM NOV2009 TO MAR2011, A TOTAL OF 51 PATIENTS UNDERWENT HEPATECTOMY WITH THE USE OF HF WHICH WERE COMPARED RETROSPECTIVELY WITH THE CONTROLLED GROUP CONSISTED OF 59 PATIENTS WHO UNDERWENT HEPATECTOMY WITH THE USE OF HA. IN THE HA GROUP, LIVER RESECTION WAS PERFORMED USING HARMONIC ACE CURVED SHEARS (ETHICON ENDO-SURGERY, CINCINNATI, OH, USA). IN HF GROUP, THE HARMONIC FOCUS CURVED SHEARS (HF) IN LIVER RESECTION. POSTOPERATIVE COMPLICATIONS INCLUDED BLOOD LOSS REQUIRING BLOOD TRANSFUSION (N=12 HA GROUP; N=1 HF GROUP); BILE LEAKAGE (N=2 HA GROUP ONLY) REQUIRING DRAIN AND WERE REMOVED AT POSTOPERATIVE DAY (POD) 9 IN ONE PATIENT AND POD 7 IN ANOTHER PATIENT BECAUSE BILE LEAKAGE STOPPED; AND ABDOMINAL ABSCESS (N=2 HA GROUP ONLY) AFTER REMOVAL OF THE DRAINS IN WHICH ONE PATIENT WAS TREATED WITH PERCUTANEOUS TRANSHEPATIC ABSCESS DRAINAGE WITH S8 SEGMENTECTOMY ON POD 12, AND THE OTHER PATIENT WAS MEDICATED BY THE ANTIBIOTICS. THE AUTHORS THOUGHT THAT POSTOPERATIVE BILE LEAKAGE OCCURRED BECAUSE GLISSON¿S SHEATH WAS NOT COMPLETELY SEALED WHEN WE USED THE HA BLINDLY IN THE DEEP LIVER PARENCHYMAL LAYER. IT WAS DIFFICULT TO SEAL THE SHEATH PRECISELY IN THE DEEP LIVER PARENCHYMAL LAYER. THE CLAMP-CRUSHING METHOD COMBINED WITH THE USE OF THE HF IS EFFECTIVE FOR LIVER RESECTION. WE CAN SEAL GLISSON¿S SHEATH AND HEPATIC VEINS WITH A DIAMETER <3 MM SAFELY, WITHOUT POSTOPERATIVE BLEEDING OR BILE LEAKAGE, WITH THE USE OF THE HF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265279 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention