BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 10594060 · Received September 28, 2020

    Report

    Report Number
    3005075853-2020-04960
    Event Type
    Injury
    Date Received
    September 28, 2020
    Report Date
    September 2, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PUBLICATION YEAR OF 2019, 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. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: 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: SAFETY AND FEASIBILITY OF LAPAROSCOPIC LIVER RESECTION FOR PATIENTS WITH LARGE OR MULTIPLE INTRAHEPATIC CHOLANGIOCARCINOMAS. A PROPENSITY SCORE BASED CASE-MATCHED ANALYSIS FROM A SINGLE INSTITUTE. AUTHOR(S): YUNFENG ZHU, MD, JIULIN SONG, MD, XI XU, MD, YIFEI TAN, MD, JIAYIN YANG, MD CITATION: MEDICINE 2019;98:49(E18307); DOI: HTTP://DX.DOI.ORG/10.1097/MD.0000000000018307. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO COMPARE THE DIFFERENCE BETWEEN OPEN HEPATECTOMY (OH) AND LAPAROSCOPIC LIVER RESECTION (LLR) IN PATIENTS WITH LARGE OR MULTIPLE INTRAHEPATIC CHOLANGIOCARCINOMAS (ICC) IN A CASE-MATCHED ANALYSIS USING PROPENSITY SCORE MATCHING (PSM). BETWEEN JAN2012 AND JUN2017, 83 PATIENTS WITH LARGE AND MULTIPLE ICC UNDERWENT LLR (N=20; AGE OF 54.3 ±15.9 YEARS; N=12 MALE AND N=8 FEMALE; BMI OF 23.0±3.4 KG/M^2) OR OH (N=63; AGE OF 56.5±10.2 YEARS; N=39 MALE AND N=24 FEMALE; BMI OF 23.5±4.4 KG/M^2). DURING DISSECTION IN LLR PROCEDURE, A LAPAROSCOPIC CAVITRON ULTRASONIC SURGICAL ASPIRATOR, HARMONIC SCALPEL (ETHICON, SOMERVILLE, NJ) AND HEM-O-LOK CLIPS (WECK, TELEFEX MEDICAL, NC) WERE USED. A MASSIVE HEMORRHAGE IN A 63-YEAR-OLD WOMAN DURING PARENCHYMAL TRANSECTION WAS REPORTED. INADEQUATE EXPOSURE RESTRAINED THE HEMOSTATIC STEPS, TITANIUM CLIPS WERE USED TO TEMPORARILY CONTROL THE BLEEDING, AND LAPAROTOMY WAS PERFORMED. THIS PATIENT ALSO ACCOUNTED FOR THE MAXIMUM BLOOD LOSS IN THE LLR COHORT AND UNDERWENT INTRAOPERATIVE TRANSFUSION. ALSO, ANOTHER PATIENT UNDERWENT INTRAOPERATIVE TRANSFUSION. POSTOPERATIVE COMPLICATIONS IN LLR GROUP INCLUDED LIVER FAILURE (N=1), AND BILIARY LEAKAGE (N=1). IN CONCLUSION, THE PRESENT STUDY SHOWED THAT PATIENTS WHO UNDERWENT LLR FOR LARGE OR MULTIPLE ICCS COULD OBTAIN SIMILAR SHORT- AND LONG-TERM OUTCOMES COMPARED WITH THOSE WHO UNDERWENT OH, AND LND WAS MORE TECHNICALLY DIFFICULT BUT FEASIBLE IN LLR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1057850 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention