BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 9507911 · Received December 20, 2019

    Report

    Report Number
    3005075853-2019-24720
    Event Type
    Injury
    Date Received
    December 20, 2019
    Report Date
    November 29, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2019. 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. WHAT WAS THE SPECIFIC INTRAOPERATIVE COMPLICATIONS THAT THE PATIENTS EXPERIENCED DURING THE STUDY? DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN.

    Description of Event or Problem · 1

    TITLE: EFFICACY OF A FIBRIN SEALANT (TISSUCOL DUO) FOR THE PREVENTION OF LYMPHOCELE AFTER LAPAROSCOPIC PELVIC LYMPHADENECTOMY: A RANDOMIZED CONTROLLED TRIAL. AUTHORS: IBON JAUNARENA, MD, RUBEN RUIZ, MD, MIKEL GOROSTIDI, MD, MS, PALOMA COBAS, MD, MARISA AVILA, MD, DAVID DEL VALLE, MD, JUAN CESPEDES, MD, AND ARANTZA LEKUONA, MD CITATION: JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY (2019) 26, 954-959; HTTPS://DOI.ORG/10.1016/J.JMIG.2018.10.002. THIS PROSPECTIVE DOUBLE-BLIND RANDOMIZED STUDY AIMED TO ASSESS THE EFFICACY OF TISSUCOL DUO SEALANT IN DECREASING THE INCIDENCE OF LYMPHOCELE (LC) AFTER LAPAROSCOPIC PELVIC LYMPHADENECTOMY (LPL) USING HARMONIC SHEARS. BETWEEN FEBRUARY 2012 AND JUNE 2016, A TOTAL OF 74 PATIENTS (MEAN AGE: 58.8 YEARS, MEAN BMI: 27.3 KG/M2) DIAGNOSED WITH GYNECOLOGIC CANCER (CERVICAL, ENDOMETRIAL, OR RESTAGING EARLY OVARIAN) SCHEDULED TO UNDERGO TRANSPERITONEAL BILATERAL LPL AS PART OF THEIR SURGICAL TREATMENT WERE INCLUDED. AFTER BILATERAL PELVIC LYMPHADENECTOMY A FIBRIN SEALANT WAS USED IN 1 HEMIPELVIS BUT NOT THE OTHER. ALL PROCEDURES WERE CARRIED OUT USING ULTRASONIC SHEARS (HARMONIC) (ETHICON). COMPLAINT INCLUDED VASCULAR COMPLICATIONS (N=4), INTRAOPERATIVE COMPLICATIONS (N=8), AND LYMPHOCELES AT SOME POINT DURING THE 1-YEAR FOLLOW-UP (N=26), OF WHOM 4 WERE SYMPTOMATIC. IN CONCLUSION, IN GYNECOLOGIC SURGERY THE SPRAYING OF TISSUCOL DUO FIBRIN SEALANT ON THE SURGICAL BED AFTER LPL PERFORMED USING ULTRASONIC SHEARS IS NOT ASSOCIATED WITH LOWER RATES OF LC OVERALL OR OF SYMPTOMATIC LC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294899 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other