BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 9668235 · Received February 4, 2020

    Report

    Report Number
    3005075853-2020-00759
    Event Type
    Injury
    Date Received
    February 4, 2020
    Report Date
    January 7, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PUBLICATION YEAR OF 2016. 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.

    Description of Event or Problem · 1

    TITLE: TOWARD ZERO: DEEP STERNAL WOUND INFECTION AFTER 1001 CONSECUTIVE CORONARY ARTERY BYPASS PROCEDURES USING ARTERIAL GRAFTS: IMPLICATIONS FOR DIABETIC PATIENTS. AUTHORS: TERESA M. KIESER, MD, M. SARAH ROSE, PHD, UTHMAN ALUTHMAN, MD, MARLENE MONTGOMERY, RN, THOMAS LOUIE, MD, AND ISRAEL BELENKIE, MD. CITATION: J THORAC CARDIOVASC SURG (2014):1-9. DOI: HTTP://DX.DOI.ORG/10.1016/J.JTCVS.2014.02.022. THE AIM WAS TO DETERMINE (1) IF THE ABSENCE OF DSWIS IN THE LAST 469 OF 1001 CONSECUTIVE OPERATIONS WAS SIGNIFICANT; (2) WHICH MEASURES EXPLAINED THE CHANGE; AND (3) THE IMPACT OF DIABETES. THIS RETROSPECTIVE ANALYSIS OF PROSPECTIVELY COLLECTED DATA INVOLVES 1001 CONSECUTIVE CORONARY ARTERY BYPASS GRAFT (CABG) OPERATIONS (MALE ¿ 780; MEAN AGE: 65±10.4 YEARS) PERFORMED WITH 98% (2928 OF 2987) ARTERIAL GRAFTS FROM JULY 18, 2003 TO OCTOBER 16, 2012. DURING THE PROCEDURE, INTERNAL THORACIC ARTERY (ITA) CONDUITS WERE HARVESTED AND SKELETONIZED, MOST WITH AN ULTRASONIC SCALPEL (HARMONIC SCALPEL; ETHICON) REPORTED COMPLICATIONS INCLUDED HARVESTED ITAS COULD NOT BE USED BECAUSE OF DAMAGE (N-?), AND BLEEDING (N-?) WHICH REQUIRED REEXPLORATION. THE MEASURES APPLIED CAUSED A SUBSTANTIAL REDUCTION IN DSWIS. KEY MEASURES INCLUDED THE USE OF CHLORHEXIDINE-ALCOHOL AND AVOIDANCE OF BITA GRAFTING IN OBESE DIABETIC FEMALES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126473 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention