BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL CURVED SHEAR

    MDR report key: 9532933 · Received December 30, 2019

    Report

    Report Number
    3005075853-2019-24772
    Event Type
    Injury
    Date Received
    December 30, 2019
    Date of Event
    January 1, 2001
    Report Date
    December 3, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K002981
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2001. MEDICAL DEVICE: 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.

    Description of Event or Problem · 1

    TITLE: ENDOSCOPIC RADIAL ARTERY HARVEST: A NEW APPROACH. AUTHOR(S): MARK H. GENOVESI, MD, LISA TORILLO, PA, JAMES FRONGER, MD, NILESH PATEL, MD, J.C MCCABE, MD, V.A SUBRAMANIAN, MD. CITATION: THE HEART SURGERY FORUM #2001-1485 4 (3): 223-225, 2001. THIS ARTICLE AIMED TO REVIEW THE MINIMALLY INVASIVE TECHNIQUE FOR OBTAINING THE RADIAL ARTERY (RA) FROM THE FOREARM. OVER A 12-MONTH PERIOD, 120 NONSELECTED PATIENTS UNDERWENT ENDOSCOPIC RADIAL ARTERY HARVESTING. IN THE PROCEDURE, A 5-MM 30-DEGREE ORBITAL ENDOSCOPIC DISSECTOR (ETHICON) WAS PASSED ABOVE THE RA IN A PLANE ABOVE THE FASCIA. THE CLEAR GLIDE (ETHICON) ENDOSCOPIC DISSECTOR WAS PLACED AND THE FASCIA WAS TRANSECTED WITH THE USE OF THE LCS C-5 HARMONIC SHEARS. ALL DISSECTION WAS CARRIED OUT WITH THE USE OF LCS C-5 HARMONIC SHEARS, DIVIDING EACH VESSEL BRANCH. INTRAOPERATIVELY, BRACHIAL ARTERY WAS INADVERTENTLY CUT IN ONE CASE NECESSITATING OPEN REPAIR. NO MAJOR ADVERSE CLINICAL EVENTS WERE OBSERVED, ALTHOUGH TRANSIENT DYSESTHESIA IN THE DORSUM OF THE HAND AND RADIAL ASPECT OF THE FOREARM DEVELOPED IN SEVERAL PATIENTS (N=?). THE DYSESTHESIA WAS REPORTED TO BE ATTRIBUTED TO CONTUSION OF THE SUPERFICIAL BRANCH OF THE RADIAL NERVE AND THE LATERAL CUTANEOUS NERVE FROM THE LARGE INSTRUMENTS USED FOR THE HARVESTINGS. ENDOSCOPIC RA HARVESTING IS A SAFE TECHNIQUE AND HAS GOOD SHORT-TERM PATENCY RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1323574 HARMONIC SCALPEL CURVED SHEAR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention