BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 18312881 · Received December 12, 2023

    Report

    Report Number
    3005075853-2023-09308
    Event Type
    Injury
    Date Received
    December 12, 2023
    Date of Event
    April 7, 2023
    Report Date
    December 12, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4), DATE SENT: 12/12/2023, B3: PUBLICATION YEAR OF 2023, 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. 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: SIMPLIFYING MINIMALLY INVASIVE RIGHT HEPATECTOMY AUTHORS: NORA NEVERMANN1 · LINDA FELDBRÜGGE1,2 · SEBASTIAN KNITTER1,2 · FELIX KRENZIEN1,2 · NATHANAEL RASCHZOK1 · GEORG LURJE1 · WENZEL SCHÖNING1 · JOHANN PRATSCHKE1 · MORITZ SCHMELZLE1 CITATION: SURGICAL ENDOSCOPY (2023); 37:5430¿5437. HTTPS://DOI.ORG/10.1007/S00464-023-09996-7 THE AIM OF THIS RETROSPECTIVE, PROSPECTIVE OBSERVATIONAL STUDY IS TO EVALUATE THE FEASIBILITY OF UGH AND COMPARES ITS INTRAOPERATIVE AND POSTOPERATIVE OUTCOME TO THE ESTABLISHED INTRAFASCIAL APPROACH (CONTROL GROUP). BETWEEN JANUARY 1ST OF 2019, AND DECEMBER 31ST OF 2020, A TOTAL OF 62 PATIENTS (25 FEMALES; MEDIAN AGE WAS 60 (16) YEARS) UNDERWENT MINIMALLY INVASIVE RIGHT HEPATECTOMY WERE INCLUDED. AMONG THESE, 16 PATIENTS WERE PERFORMED USING UGH. AFTER 2:1 PROPENSITY SCORE MATCHING, 16 CASES WERE INCLUDED TO THE STUDY GROUP (UGH) AND 32 MATCHED CASES TO THE CONTROL GROUP. UGH WAS CONDUCTED BASED ON A STANDARDIZED 10-STEP-PROTOCOL WHICH INCLUDES THE FOLLOWING: THE HEPATODUODENAL LIGAMENT IS ENCIRCLED WITH A MERSILENE TAPE; LAPAROSCOPIC PARENCHYMAL TRANSECTION IS PERFORMED USING ULTRASONIC SHEARS (THUNDERBEAT®, OLYMPUS MEDICAL EUROPA, HAMBURG, GERMANY; HARMONIC ® HD 1000I, JOHNSON & JOHNSON MEDICAL GMBH ETHICON, NORDERSTEDT, GERMANY) FOR SURFACE TRANSECTION AND WATER JET DISSECTION (ERBEJET® 2, ERBE MEDICAL; TÜBINGEN, GERMANY) FOR DEEPER TRANSECTION. VEINS ARE LIGATED USING POLYMER CLIPS (LAPRO-CLIP¿, MEDTRONIC, MEERBUSCH, GERMANY); FOR ROBOTIC RESECTIONS, THE SUPERFICIAL AND DEEP PARENCHYMAL DISSECTION IS PERFORMED USING ULTRASONIC SHEARS (HARMONIC ACE ®, JOHNSON & JOHNSON MEDICAL GMBH ETHICON, NORDERSTEDT, GERMANY). FOR DEEP TISSUE DISSECTION, A MODIFIED CLAMP-CRUSH TECHNIQUE IS APPLIED FOR SAFE IDENTIFICATION OF RELEVANT STRUCTURES. CENTRAL STAPLER DISSECTION OF THE RIGHT HEPATIC PEDICLE (ECHELON¿ + STAPLER, RELOADS: GST60B (60 MM), JOHNSON & JOHNSON MEDICAL GMBH ETHICON, NORDERSTEDT, GERMANY) 7. STAPLER DISSECTION OF THE RIGHT HEPATIC VEIN (ECHELON¿ + STAPLER, RELOADS: GST60B, S. ABOVE). FOR THE STANDARD MINIMAL INVASIVE RIGHT HEPATECTOMY (CONTROL GROUP), AFTER THE PARENCHYMAL DISSECTION, A LINEAR STAPLER (ECHELON¿ + STAPLER, RELOADS: GST60B (60 MM), JOHNSON & JOHNSON MEDICAL GMBH ETHICON, NORDERSTEDT, GERMANY) WAS USED TO DISSECT THE RIGHT BILE DUCT AND THE RIGHT HEPATIC VEIN. REPORTED COMPLICATIONS IN THE UGH INCLUDE (N=2) MAJOR POSTOPERATIVE COMPLICATIONS (CLAVIEN DINDO = IIIA). IN THE CONTROL GROUP, (N=8) MAJOR POSTOPERATIVE COMPLICATIONS (CLAVIEN DINDO = IIIA) AND (N=9) BILE LEAK. IN CONCLUSION, UGH APPEARS TO BE AT LEAST COMPARABLE TO THE STANDARD TECHNIQUE IN TERMS OF INTRAOPERATIVE AND POSTOPERATIVE OUTCOMES. ACCORDINGLY, TRANSECTION OF THE RIGHT HEPATIC ARTERY AND RIGHT PORTAL VEIN PRIOR TO THE TRANSECTION PHASE CAN BE OMITTED, AT LEAST IN SELECTED CASES. THESE RESULTS NEED TO BE CONFIRMED IN A PROSPECTIVE AND RANDOMIZED TRIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1111394 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention