BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 9511441 · Received December 23, 2019

    Report

    Report Number
    3005075853-2019-24738
    Event Type
    Injury
    Date Received
    December 23, 2019
    Report Date
    December 2, 2019
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICE: BATCH # UNK. DATE OF EVENT: PUBLICATION YEAR FOR THE JOURNAL ARTICLE IS 2014. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REVIEW OF A JOURNAL ARTICLE, TITLE: ROBOT-ASSISTED LAPAROSCOPIC HEPATECTOMY: THE HENRI-MONDOR EXPERIENCE AUTHOR: SALLOUM C.; TAYAR C.; LAURENT A.; MALEK A.; COMPAGNON P.; MEMEO R.; DE ANGELIS N.; PASCAL G.; AZOULAY D. CITATION: HPB. CONFERENCE: 11TH WORLD CONGRESS OF THE INTERNATIONAL HEPATO-PANCREATO-BILIARY ASSOCIATION. SEOUL SOUTH KOREA. 16 (SUPPL. 2); P535; 2014. THIS STUDY DISCUSSED ABOUT THE ROBOT-ASSISTED LAPAROSCOPIC HEPATECTOMY. BETWEEN MARCH 2011 AND JUNE 2013, 24 HEPATIC RESECTIONS FOR BOTH BENIGN AND MALIGNANT LESIONS BY ROBOT-ASSISTED LAPAROSCOPIC APPROACH. DURING THE PROCEDURE, THE DISSECTION WAS CARRIED OUT WITH THE BIPOLAR FORCEPS ON THE LEFT ARM OF THE SURGEON AND THE HARMONIC CURVED SHEARS (ETHICON) ON THE RIGHT. REPORTED COMPLICATIONS INCLUDED INTRAOPERATIVE BLOOD LOSS OF 169.6 ± 165.2 ML (RANGE: 20-700 ML) (N=?), IN WHICH ONE OPEN CONVERSION WAS NEEDED; PARTIAL THROMBOSIS IN THE RIGHT ANTERIOR PORTAL BRANCH (N=1); AND ENTEROCUTANEOUS FISTULA (N=1) WHICH WAS TREATED CONSERVATIVELY. IN CONCLUSION, ROBOT-ASSISTED LAPAROSCOPIC HEPATECTOMY IS FEASIBLE AND SAFE. FURTHER EVALUATION WITH CLINICAL TRIALS IS REQUIRED TO ASSESS FOR IMPROVEMENT IN OUTCOMES AND TO VALIDATE ITS REAL BENEFITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308585 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention