BEUDAMED
    FDA Adverse Event Death Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 10602829 · Received September 29, 2020

    Report

    Report Number
    3005075853-2020-05030
    Event Type
    Death
    Date Received
    September 29, 2020
    Report Date
    September 2, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2020. 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 CAUSE OF DEATH (LOW CARDIAC OUTPUT ONLY, MEDIASTINITIS ONLY, OR BOTH) IN THE TWO PATIENTS WHO UTILIZED HARMONIC SCALPEL AND WERE THE CAUSES OF DEATH RELATED TO THE USE OF THE 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. 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 · 1

    TITLE: ULTRASTRUCTURAL INVESTIGATIONS OF ARTERIAL BYPASS CONDUITS AFTER THE USE OF DIFFERENT HARVESTING TECHNIQUES USING AN ELECTRON MICROSCOPE AUTHOR(S): IHSAN SAMI UYAR, MD, DOGAN KAHRAMAN, MD GÖKHAN KESKIN, MD, EMJED KHALIL, MD CITATION: THE HEART SURGERY FORUM #2020-2657 23 (1), 2020; DOI: 10.1532/HSF.02657. THE AIM OF THIS STUDY WAS TO PERFORM MORPHOMETRIC ANALYSIS OF ARTERIAL CONDUITS HARVESTED BY HARMONIC SCALPEL IN CORONARY ARTERY BYPASS GRAFTING (CABG) PATIENTS. A TOTAL OF 100 PATIENTS (59 MALE) WHO UNDERWENT CABG SURGERY WERE INCLUDED IN THE STUDY AND WERE DIVIDED INTO TWO GROUPS BASED ON THE HARVESTING TECHNIQUES. IN GROUP 1 (N=50; N=33 MALE AND N=17 FEMALE; AGE OF 56.3±7.5 YEARS; BODY MASS INDEX OF 24 KG/M^2 [20-42 KG/M^2), A ULTRASONIC SCALPEL WAS USED IN 50 PATIENTS FOR HARVESTING ARTERIAL CONDUITS (50 LEFT INTERNAL THORACIC ARTERY [LITA] AND 50 RADIAL ARTERY [RA]). IN GROUP 2 (N=50; N=31 MALE AND N=19 FEMALE; AGE OF 59±9.3 YEARS; BODY MASS INDEX OF 22 KG/M^2 (19-31 KG/M^2), CONDUITS WERE HARVESTED USING LOW-VOLTAGE ELECTROCAUTERY (50 LITA AND 50 RA). IN GROUP 1, THE PREPARATION OF 100 ARTERIAL CONDUITS WAS PERFORMED USING (HARMONIC SCALPEL, ETHICON, ENDO-SURGERY, SOMERVILLE, NJ), WHICH CONSISTED OF A GENERATOR, CABLE SYSTEM, CAUTERY TIP, AND FOOT PEDAL. FOR LITA HARVESTING IN GROUP 1, THE ENDOTHORACIC FASCIA WAS CUT AND DISSECTED FROM 1 CM MEDIAL USING THE CURVED END OF THE HARMONIC SCALPEL. TWO PATIENTS DIED AFTER SURGERY BECAUSE OF LOW CARDIAC OUTPUT (N=1) WHICH INITIALLY REPLACED THE LITA USING A SAPHENOUS VEIN; AND MEDIASTINITIS (N=1). IN GROUP 1, WE DETECTED MILD TO MODERATE ENDOTHELIAL OR SUBENDOTHELIAL PATHOLOGY IN 5 SPECIMENS (10%) (3 LITA, 6%; 2 RA, 4%). THE INVESTIGATION DEMONSTRATES FOR THE FIRST TIME THAT HARVESTING OF LITA AND THE RA USING THE HARMONIC SCALPEL IS ASSOCIATED WITH BETTER PRESERVATION OF ENDOTHELIAL AND SUBENDOTHELIAL INTEGRITY COMPARED WITH THE STANDARD HARVESTING METHOD. IN THE HARMONIC SCALPEL GROUP, WE DETECTED ENDOTHELIAL OR SUBENDOTHELIAL PATHOLOGY IN ONLY 5 SPECIMENS. ACCORDING TO OUR INVESTIGATION, THIS TECHNIQUE DECREASED THE HISTOPATHOLOGIC CHANGES OF CONDUITS SIGNIFICANTLY COMPARED WITH LOW-VOLTAGE ELECTROCAUTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065666 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death