BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 22951595 · Received September 3, 2025

    Report

    Report Number
    3005075853-2025-06955
    Event Type
    Injury
    Date Received
    September 3, 2025
    Date of Event
    January 1, 2025
    Report Date
    September 3, 2025
    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). DATE SENT: 9/3/2025. B3: PUBLICATION YEAR OF 2025. 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. 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. 9. FDA CORRECTION/ REMOVAL REPORTING NO.

    Description of Event or Problem · 0

    TITLE: TO EVALUATE THE FEASIBILITY AND SAFETY OF LAPAROSCOPIC LEFT HEPATECTOMY FOR HEPATOLITHIASIS IN PATIENTS WITH PREVIOUS ABDOMINAL SURGERY SAFETY AND FEASIBILITY OF LAPAROSCOPIC LEFT HEPATECTOMY FOR THE TREATMENT OF HEPATOLITHIASIS PATIENTS WITH PREVIOUS ABDOMINAL SURGERY. CITATION: NOT PROVIDED. AUTHORS: LINGPENG LIU. THE AIM OF THIS STUDY IS TO INVESTIGATE THE FEASIBILITY AND SAFETY OF LAPAROSCOPIC LEFT HEPATECTOMY (LLH) FOR THE TREATMENT OF HEPATOLITHIASIS PATIENTS WITH A PREVIOUS HISTORY OF ABDOMINAL SURGERY (PAS). FROM AUGUST 2017 TO AUGUST 2019, A TOTAL OF 111 PATIENTS WHO UNDERWENT LLH FOR CURING HEPATOLITHIASIS (WITH PAS, N = 41; WITHOUT PAS, N = 70). THERE WERE 8 MALE AND 33 FEMALE PATIENTS IN THE ABDOMINAL SURGERY HISTORY GROUP; THERE WERE MALE PATIENTS IN THE NO PREVIOUS ABDOMINAL SURGERY HISTORY GROUP THERE WERE 21 PATIENTS AND 49 FEMALE PATIENTS. AGE DID NOT DIFFER BETWEEN THE TWO GROUPS (P > 0.05). THE HARMONIC SCALPEL (ETHICON, JOHNSON & JOHNSON), ELECTRIC COAGULATION ROD, ATRAUMATIC FORCEPS AND SUCTION APPARATUS WERE USED TO COOPERATE WITH EACH OTHER TO PULL APART THE ADHESION, LIGAMENTUM TERES, FALCIFORM LIGAMENT AND PERIHEPATIC LIGAMENT TO EXPOSE THE SURGICAL FIELD, ESPECIALLY THE REGION OF FIRST PORTA HEPATIS WAS CLEARLY DISSECTED. THE MEAN FOLLOW-UP DURATION WAS NOT REPORTED. REPORTED COMPLICATIONS: HARMONIC SCALPEL (ETHICON). (N=?) BLEEDING. TREATMENT: NOT REPORTED. (N=6) BILE LEAKAGE POSTOPERATIVE INDICATORS OF LAPAROSCOPIC LEFT HEPATECTOMY (LLH) WITH AND WITHOUT PREVIOUS (PREVIOUS ABDOMINAL SURGERY) PAS. TREATMENT: NOT REPORTED. (N=2) BILE LEAKAGE POSTOPERATIVE PARAMETERS IN PATIENTS WITH AND WITHOUT PRIOR (PREVIOUS ABDOMINAL SURGERY) PAS UNDERGOING LLHH. TREATMENT: NOT REPORTED. (N=1) POST PROCEDURAL HEMORRHAGE GROUP A-1. TREATMENT: NOT REPORTED. (N=5) BILE LEAKAGE POSTOPERATIVE MEASURES FOR PATIENTS RECEIVING LAPAROSCOPIC LEFT HEPATECTOMY (LLLH) WITH AND WITHOUT PRIOR (PREVIOUS ABDOMINAL SURGERY) PAS. TREATMENT: NOT REPORTED. IN CONCLUSION, LAPAROSCOPIC LEFT HEPATECTOMY IS SAFE AND FEASIBLE FOR PATIENTS WITH HEPATOLITHIASIS WHO HAVE A PREVIOUS HISTORY OF ABDOMINAL SURGERY AND IS WORTHY OF EXTENSIVE APPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2234050 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention