BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 9668785 · Received February 4, 2020

    Report

    Report Number
    3005075853-2020-00767
    Event Type
    Injury
    Date Received
    February 4, 2020
    Report Date
    January 7, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PUBLICATION YEAR OF 2017. 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WHAT IS THE SPECIFIC NUMBER OF PATIENTS WHO HAD SIGNIFICANT OPERATIVE BLOOD LOSS, POSTOPERATIVE BLEEDING, BILIARY LEAK AND ABDOMINAL FLUID COLLECTION WITH THE USE OF ETHICON DEVICE (HARMONIC SCALPEL). AS PER ARTICLE, 2 DEVICES WERE USED IN THE PROCEDURE: HARMONIC SCALPEL WHICH IS AN ETHICON DEVICE AND LIGASURE WHICH IS A NON-ETHICON? DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN.

    Description of Event or Problem · 1

    TITLE: SHORT-TERM OUTCOMES OF LAPAROSCOPIC VS. OPEN LIVER RESECTION FOR HEPATOCELLULAR ADENOMA: A MULTICENTER PROPENSITY SCORE ADJUSTMENT ANALYSIS BY THE AFC-HCA-2013 STUDY GROUP. AUTHORS: FILIPPO LANDI, NICOLA DE¿ ANGELIS, OLIVIER SCATTON, XAVIER VIDAL, AHMET AYAV, FABRICE MUSCARI, SAFI DOKMAK, GUIDO TORZILLI, NICOLAS DEMARTINES, OLIVIER SOUBRANE, DANIEL CHERQUI, JEAN HARDWIGSEN, ALEXIS LAURENT. CITATION: SURG ENDOSC (2017) 31:4136¿4144; DOI: 10.1007/S00464-017-5466-4. THE AIMED OF THIS RETROSPECTIVE STUDY WAS TO INVESTIGATE THE EFFECTS OF THE SURGICAL APPROACH ON THE POSTOPERATIVE MORBIDITIES OF BOTH MINOR AND MAJOR LIVER RESECTIONS. BETWEEN 1989 AND 2013, 533 PATIENTS UNDERWENT OPEN OR LAPAROSCOPIC HEPATECTOMIES. THE PATIENTS WERE DIVIDED INTO TWO GROUPS: LAPAROSCOPIC LIVER RESECTIONS (LLRS) (N=208; FEMALE=194; MEAN AGE=39.6 YEARS, AGE RANGE=31.5 ¿ 45.6 YEARS; MEAN BMI=23.2 KG/M^2, BMI RANGE= 20.7 ¿ 28.0 KG/M^2) AND OPEN LIVER RESECTIONS (OLRS) (N=325; FEMALE=275; MEAN AGE=38.7 YEARS, AGE RANGE=31.3 ¿ 45.9 YEARS; MEAN BMI=24.2 KG/M^2, BMI RANGE= 20.8 ¿ 27.7 KG/M^2). DURING THE PROCEDURE OF LLR, LIVER PARENCHYMA TRANSECTIONS WERE PERFORMED USING BOTH AN ULTRASONIC DISSECTION DEVICE WITH BIPOLAR CAUTERY AND THE LIGASURE OR THE HARMONIC SCALPEL (ETHICON). REPORTED COMPLICATIONS INCLUDED OPERATIVE BLOOD LOSS (MEAN=93 ML, RANGE=50 ¿ 271 ML) (N=?) WHICH HAD TRANSFUSION OF 8 RBC UNITS; POSTOPERATIVE BLEEDING (N=?); BILIARY LEAK (N=?); ABDOMINAL FLUID COLLECTION (N=?). IN CONCLUSION, LAPAROSCOPY CAN ACHIEVE SHORT-TERM OUTCOMES SIMILAR TO THOSE OF OPEN SURGERY FOR HEPATOCELLULAR ADENOMAS AND HAS THE ADDITIONAL BENEFITS OF A REDUCED BLOOD LOSS, NEED FOR TRANSFUSION, AND A SHORTER HOSPITAL STAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126821 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention