BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 15708072 · Received November 1, 2022

    Report

    Report Number
    3005075853-2022-07450
    Event Type
    Injury
    Date Received
    November 1, 2022
    Date of Event
    May 4, 2022
    Report Date
    November 1, 2022
    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 · 0

    (B)(4). PUBLICATION YEAR OF 2022. 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. DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    TITLE: LAPAROSCOPIC ANATOMICAL VERSUS NON-ANATOMICAL HEPATECTOMY IN THE TREATMENT OF HEPATOCELLULAR CARCINOMA: A RANDOMISED CONTROLLED TRIAL AUTHORS: KEXI LIAO A, KAIJIN YANG A,B, LI CAO A, YAO LU A, BOWEN ZHENG A, XUESONG LI A, XIAOJUN WANG A, JIANWEI LI A, JIAN CHEN A, SHUGUO ZHENG A,* CITATION: INTERNATIONAL JOURNAL OF SURGERY (2022);102 (106652):1-8. HTTPS://DOI (B)(4). A PROSPECTIVE RANDOMISED CONTROLLED TRIAL (RCT) WAS CONDUCTED TO COMPARE THE PERIOPERATIVE AND FOLLOW-UP OUTCOMES OF PATIENTS WITH HEPATOCELLULAR CARCINOMA (HCC) TREATED BY LAPAROSCOPIC ANATOMICAL HEPATECTOMY (LAH) AND NON-ANATOMICAL HEPATECTOMY (LNAH). BETWEEN MARCH 2013 AND JAN 2018, A TOTAL OF 385 PATIENTS WITH A DIAGNOSIS OF HCC WERE INCLUDED IN THE STUDY. AMONG THESE, 192 PATIENTS (161 MALE AND 31 FEMALE; MEAN AGE OF 52.92 ± 11.30 YEARS) UNDERWENT LAH AND 193 (168 MALE AND 25 FEMALE; MEAN AGE OF 51.75 ± 10.64 YEARS) UNDERWENT LNAH. SURGERY WAS PERFORMED USING ULTRASONIC SCALPEL (ETHICON ENDO-SURGERY, CINCINNATI, OH), VASCULAR CLIPS (CONTINUOUS TITANIUM CLIPS, ETHICON ENDO-SURGERY), AND ENDOSCOPIC LINEAR CUTTER (ECHELON 45/60 ENDOPATH STAPLER, USA). REPORTED COMPLICATIONS INCLUDE CONVERSION TO LAPAROTOMY DUE TO RIGHT HEPATIC VEIN INJURY (N=6), MIDDLE HEPATIC VEIN INJURY (N=6), UNCONTROLLED HAEMORRHAGE/MASSIVE BLEEDING DURING PARENCHYMAL TRANSECTION (N=5); HEPATIC INSUFFICIENCY (N=3); BILIARY LEAKAGE (N=12); PERITONEAL ENCAPSULATED EFFUSION (N=14); ASCITES (N=2); WOUND INFECTION (N=2). IN CONCLUSION, LAH VERSUS LNAH FOR SELECTED HEPATOCELLULAR CARCINOMA (HCC) PATIENTS WAS ASSOCIATED WITH INCREASED DISEASE-FREE SURVIVAL (DFS), LOWER INTRAHEPATIC IPSILATERAL RECURRENCE RATE, COMPARABLE LONG-TERM OS AND POSTOPERATIVE COMPLICATIONS. LAH IS THEREFORE RECOMMENDED FOR SELECTED HCC PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059389 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention