BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 22375382 · Received July 1, 2025

    Report

    Report Number
    3005075853-2025-05019
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    June 7, 2017
    Report Date
    July 1, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/1/2025. B3: PUBLICATION YEAR OF 2017. D4: BATCH # UNK. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF PUBLISHED SCIENTIFIC ARTICLES CAPTURED UNDER CAPA-014204. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY 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: PER THE JOURNAL ARTICLE IT STATES: ¿THERE WAS BLOOD LOSS¿ WAS THERE ANY INTERVENTION FOR THE PATIENTS THAT HAD THE BLOOD LOSS? IF YES, WHAT WERE THOSE INTERVENTIONS? PER THE JOURNAL ARTICLE IT STATES: ¿INFECTIONS¿ WHAT WAS THE TREATMENT FOR INFECTIONS? PER THE JOURNAL ARTICLE IT STATES; ¿ASCITES¿ WHAT WAS THE TREATMENT FOR ASCITES? PER THE JOURNAL ARTICLE IT STATES: ¿LEAKAGE¿ WHAT WAS THE TREATMENT FOR LEAKAGE? PLEASE PROVIDE THE TOTAL NUMBER OF PATIENTS WHO HAD BLOOD LOSS OF MORE THAN 500ML, ASCITES, BILIARY LEAKAGE, AND INFECTIOUS COMPLICATION AND USED HARMONIC SCALPEL? DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. HOW ARE THE PATIENTS CURRENTLY DOING? 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

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: LAPAROSCOPIC LEFT LIVER RESECTIONS: HOW FAR CAN WE GO? AUTHOR/S: GIADA PATTARO, DAVID FUKS, HADRIEN TRANCHART, GIUSEPPE MARIA ETTORRE, AMAL SUHOOL, CHRISTOPHE BOURDEAUX, PANAGIOTIS LAINAS, IBRAHIM DAGHER, BRICE GAYET. CITATION: SURG ENDOSC (2017) 31:5303¿5311, DOI 10.1007/S00464-017-5606-X. THE AIM OF THIS RETROSPECTIVE MULTICENTER STUDY WAS TO EVALUATE POSTOPERATIVE OUTCOMES IN PATIENTS SUBMITTED TO LAPAROSCOPIC ANATOMIC HEPATECTOMIES OF THE LEFT LIVER SEGMENTS RANGING FROM UNISEGMENTECTOMY TO EXTENDED LEFT HEPATECTOMIES, ANALYZING SAFETY AND FEASIBILITY, AND TO COMPARE THE RESULTS AMONG GROUPS OF THESE DIFFERENT PROCEDURES. FROM OCTOBER 1990 TO MARCH 2016, A TOTAL OF 190 PATIENTS FROM 3 CENTERS (2 FROM FRANCE AND 1 FROM ITALY) WERE SELECTED AND WERE DIVIDED BASED ON THE EXTENSION OF LIVER RESECTION- 25 UNDERWENT A UNISEGMENTECTOMY OF SEGMENT 2, 3 OR 4 (GROUP 1: N=13 MALES), 116 HAD LEFT LATERAL SECTIONECTOMIES (GROUP 2: N=69 MALES), 27 SUBMITTED TO LEFT HEPATECTOMIES (GROUP 3: N=20 MALES) AND 22 HAD EXTENDED LEFT HEPATECTOMIES (GROUP 4: N=7 MALES). ENERGY SOURCES AND PARENCHYMAL DIVISION TECHNIQUES VARIED THROUGHOUT THE STUDY PERIOD AND INCLUDED THE ULTRASONIC DISSECTOR, THE HARMONIC SCALPEL- PRIMARILY SONOSURG AND MORE RECENTLY THE HARMONIC (ETHICON) OR THE THUNDERBEAT. COMPLAINTS INCLUDES BLOOD LOSS OF MORE THAN 500ML (N=?), ASCITES (N=?), BILIARY LEAKAGE (N=?), AND INFECTIOUS COMPLICATION (N=?). IN CONCLUSION, EXTENDED LEFT LAPAROSCOPIC ANATOMICAL LIVER RESECTIONS APPEAR TO BE FEASIBLE AND SAFE WHEN PERFORMED BY EXPERIENCED SURGEONS IN BOTH LAPAROSCOPIC AND LIVER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1452720 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