BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9383083 · Received November 27, 2019

    Report

    Report Number
    3005075853-2019-23842
    Event Type
    Injury
    Date Received
    November 27, 2019
    Date of Event
    January 1, 2011
    Report Date
    October 30, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 11/27/2019 DATE OF EVENT: PUBLICATION YEAR OF 2011. 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: A SINGLE CENTER COMPARISON OF OUTCOMES IN HEPATIC RESECTIONS USING TWO DIFFERENT DEVICES FOR PARENCHYMAL DIVISION. AUTHOR/S: BODZIN A.S.; FRANK A.M.; RAMIREZ C.G.; LEIBY B.E.; MALEY W.M.; DORIAC. WEB ADDRESS: HCITATION: HPB. 13 (SUPPL. 1) (PP 5), 2011; DOI: HTTP://DX.DOI.ORG/10.1111/J.1477. THIS RETROSPECTIVE STUDY AIMED TO EVALUATE THE SAFETY AND EFFICACY OF TWO DEVICES USED IN PARENCHYMAL DIVISION DURING HEPATIC RESECTIONS. FROM 2004 TO 2010, A TOTAL OF 47 PATIENTS WHO UNDERWENT LIVER RESECTION WERE INCLUDED IN THE STUDY. TISSUELINK MONOPOLAR FLOATING BALL (TL) WITH EITHER THE ULTRASONIC DISSECTOR (CUSA) (N=27) OR HARMONIC SCALPEL (HS) (ETHICON) (N=20) WERE USED IN THE PROCEDURE. REPORTED COMPLICATIONS IN HS GROUP INCLUDED MEDIAN ESTIMATED BLOOD LOSS (EBL) OF 250 ML (N=?) IN WHICH 2 PATIENTS WERE TRANSFUSED INTRAOPERATIVELY; BILE LEAK (N=1); AND PERIOPERATIVE DEATH (N=1). THE RESULTS OF THIS STUDY SHOWED THAT THE HARMONIC SCALPEL WITH TL IS A SAFE, EFFECTIVE METHOD OF PARENCHYMAL DIVISION WITH SIGNIFICANTLY LESS EBL AND LENGTH OF STAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1179825 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention