BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 13157006 · Received January 4, 2022

    Report

    Report Number
    3005075853-2022-00012
    Event Type
    Injury
    Date Received
    January 4, 2022
    Date of Event
    August 15, 2021
    Report Date
    January 4, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PUBLICATION YEAR OF 2021. 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. 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: EARLY TO MIDTERM SURVIVAL OF PATIENTS WITH DEEP STERNAL WOUND INFECTION MANAGED WITH LAPAROSCOPICALLY HARVESTED OMENTUM. AUTHORS: MOHAMED MARZOUK, RICHARD BAILLOT, DIMITRIS KALAVROUZIOTIS, NAWAL AMHIS, JOSEPH NADER, FREDERIC S HOULD, LAURENT BIERTHO, SIAMAK MOHAMMADI, TAREK MALAS. CITATION CITE: J CARD SURG. 2021;36:4083¿4089. DOI: 10.1111/JOCS.15955. THE OBJECTIVE OF THIS STUDY WAS TO EVALUATE OUTCOMES OF PATIENTS WITH DSWI MANAGED WITH TRANSPOSITION OF LAPAROSCOPICALLY HARVESTED OMENTUM (LHO). BETWEEN 2000 AND 2020, A TOTAL OF 38,623 ADULT PATIENTS WHO UNDERWENT FULL MEDIAN STERNOTOMY FOR CARDIAC SURGERY WERE ANALYZED RETROSPECTIVELY AT OUR INSTITUTION. DSWI OCCURRED IN 455 (1.2%), OF WHOM 364 (93.2%) WERE MANAGED WITH PECTORALIS MYOCUTANEOUS FLAP (PMF) AND 33 (7.2%) WITH LHO. ULTRASOUND SCISSORS WITH BIPOLAR COAGULATION (ETHICON, ENDO-SURGERY INC.) WERE USED. IN ALL PATIENTS, TWO SILASTIC DRAINS (BLAKE DRAIN; ETHICON, INC., A JOHNSON & JOHNSON COMPANY) WERE PLACED IN THE SUBCUTANEOUS AND PECTORALIS DISSECTION PLANES. REPORTED COMPLICATIONS INCLUDED REINFECTION POSTGRAFTING WITH LAPAROSCOPICALLY HARVESTED OMENTUM (LHO) (N=1), SEPTICEMIA (N=5). IN CONCLUSION USE OF LHO IS A SAFE AND VIABLE ALTERNATIVE TO TRADITIONAL MYOCUTANEOUS FLAPS TO MANAGE COMPLEX DSWI. EARLY AND LATE SURVIVAL WERE FAVORABLE IN THIS HIGHRISK POPULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495718 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention