BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 20514938 · Received October 23, 2024

    Report

    Report Number
    3005075853-2024-07986
    Event Type
    Injury
    Date Received
    October 23, 2024
    Date of Event
    February 13, 2023
    Report Date
    October 23, 2024
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 10/23/2024. B3: PUBLICATION YEAR OF 2023. D4: BATCH # UNK. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. 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: PREVIOUS NON-HEPATECTOMY ABDOMINAL SURGERY DID NOT INCREASE THE DIFFICULTY IN LAPAROSCOPIC HEPATECTOMY FOR HEPATOCELLULAR CARCINOMA: A CASE-CONTROL STUDY IN 100 CONSECUTIVE PATIENTS. AUTHORS: YI-HSUAN LEE, HSIU-HSIEN LIN, TSAI-LING KUO, MING-CHE LEE, YEN-CHENG CHEN CITATION: TZU CHI MEDICAL JOURNAL 2023; 35 (3): 247-252. DOI: 10.4103/TCMJ.TCMJ_293_22. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO ASSESS THE DIFFICULTY OF PERFORMING LAPAROSCOPIC HEPATECTOMY (LH) FOR PATIENTS WITH HEPATOCELLULAR CARCINOMA (HCC) AND A HISTORY OF NONHEPATECTOMY ABDOMINAL SURGERY (AS) DURING THE INITIAL DEVELOPING PERIOD OF LH. BETWEEN JANUARY 2013 TO JUNE 2021, A TOTAL OF 100 PATIENTS (80 MALE AND 20 FEMALE) WITH PRIMARY HCC UNDERGOING LH WERE INCLUDED IN THE STUDY. PATIENTS WERE CLASSIFIED INTO THE FOLLOWING TWO GROUPS DEPENDING ON THE HISTORY OF NONHEPATECTOMY AS: PATIENTS WITH A HISTORY OF NONHEPATECTOMY (AS GROUP, N = 23) AND PATIENTS WITHOUT A HISTORY OF ANY AS (NON-AS GROUP, N = 77). THE MEAN AGE OF PATIENTS WAS SIMILAR IN BOTH THE GROUPS (67 VS. 66 IN THE AS AND NON-AS GROUPS, RESPECTIVELY. ADHESIOLYSIS AND PARENCHYMAL TRANSECTION WAS PERFORMED BY ELECTROCAUTERY, ULTRASONIC DEVICE (HARMONIC SCALPEL®, ETHICON, CINCINNATI, OH, USA), OR VESSEL SEALING DEVICE (LIGASURE, MEDTRONIC, MINNEAPOLIS, MN, USA). THE OVERALL MEDIAN FOLLOW-UP DURATION WAS 29 MONTHS. REPORTED COMPLICATIONS INCLUDE SURGICAL COMPLICATIONS (N=?), UNCONTROLLABLE BLEEDING FROM INFERIOR HEPATIC VEIN WITH UNSTABLE HEMODYNAMIC STATUS DURING PARENCHYMA TRANSECTION (N=?), AND MASSIVE BLEEDING DURING PARENCHYMA TRANSECTION (N=?). IN CONCLUSION, HISTORY OF PREVIOUS NONHEPATECTOMY AS CAN LEAD TO LONGER NONPARENCHYMAL TRANSECTION TIME INSTEAD OF CONVERSION AND DID NOT INCREASE THE DIFFICULTY. PROLONGED NONPARENCHYMAL TRANSECTION TIME DID NOT INCREASE THE SURGICAL COMPLICATIONS, PROLONG THE POSTOPERATIVE HOSPITAL STAY, AND COMPROMISE THE SURVIVAL OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317072 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention GENERATOR AND HANDPIECE