BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 17462626 · Received August 4, 2023

    Report

    Report Number
    3005075853-2023-05508
    Event Type
    Injury
    Date Received
    August 4, 2023
    Date of Event
    June 9, 2022
    Report Date
    August 4, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 8/4/2023. B3: PUBLICATION YEAR OF 2022. D4: 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. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. NO FURTHER INFORMATION WILL BE PROVIDED BECAUSE WE CAN¿T GET ANY ADDITIONAL INFORMATION FROM THE AUTHOR. 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 LIVER RESECTION CAN BE PERFORMED SAFELY WITHOUT INTRAOPERATIVE DRAIN PLACEMENT. AUTHORS: MOTOKAZU SUGIMOTO, NAOTO GOTOHDA, MASASHI KUDO, SHIN KOBAYASHI, SHINICHIRO TAKAHASHI, MASARU KONISHI. CITATION CITE: SURGICAL ENDOSCOPY (2022) 36:9019¿9031. HTTPS://DOI.ORG/10.1007/S00464-022-09364-X. THIS SINGLE-CENTER, RETROSPECTIVE STUDY AIMED TO EVALUATE THE NEED FOR INTRAOPERATIVE DRAIN PLACEMENT (IDP) IN LAPAROSCOPIC LIVER RESECTION (LLR). A TOTAL OF 607 PATIENTS (AGES 29-89 YEARS OLD; 411 WERE MALES) WHO UNDERWENT LLR FOR LIVER TUMOR BETWEEN JANUARY 2015 AND AUGUST 2021 WERE INCLUDED. OF THE TOTAL 607 PATIENTS, 93 UNDERWENT IDP. PROPENSITY SCORE MATCHING WAS PERFORMED USING VARIABLES OF OPERATION TYPE THAT WERE SHOWN TO BE DIFFERENT BETWEEN PATIENTS WITH AND WITHOUT IDP IN THE ORIGINAL COHORT. THE PATIENT COHORT AFTER MATCHING INCLUDED 93 AND 89 PATIENTS WITH AND WITHOUT IDP, RESPECTIVELY. CLAMP-CRUSHING TECHNIQUE WITH LAPAROSONIC COAGULATING SHEARS (HARMONIC ACE + OR HD 1000I; ETHICON ENDO- SURGERY, CINCINNATI, OH, USA) WAS USED FOR LIVER TRANSECTION. THE INCIDENCE OF POSTOPERATIVE COMPLICATIONS WAS MONITORED FOR 90 DAYS AFTER SURGERY FOR EACH PATIENT. REPORTED COMPLICATIONS INCLUDE 4 INCISIONAL SURGICAL SITE INFECTION (SSI), 14 ORGAN/SPACE SSI (ABSCESS (N=12), BILE LEAKAGE (N=1), COLONIC PERFORATION (N=1). IN CONCLUSION, THIS STUDY DEMONSTRATED THAT LLR COULD BE PERFORMED SAFELY WITHOUT IDP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1953388 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Required Intervention