BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9432943 · Received December 6, 2019

    Report

    Report Number
    3005075853-2019-24069
    Event Type
    Injury
    Date Received
    December 6, 2019
    Date of Event
    January 1, 2012
    Report Date
    November 11, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2012. BATCH # UNK. THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ENTITLED: EIGHT YEAR EXPERIENCE WITH ENDOSCOPIC RADIAL ARTERY HARVEST AT A CANADIAN CENTRE. AUTHOR/S: SWINAMER S.A.; FOX S.; CHU M.; NOVICK R.; QUANTZ M.; MYERS M.; GUO R.; MCKENZIE N.; SY J.; KIAII B. CITATION: CANADIAN JOURNAL OF CARDIOLOGY. CONFERENCE: 65TH ANNUAL MEETING OF THE CANADIAN CARDIOVASCULAR SOCIETY. TORONTO, ON CANADA. CONFERENCE PUBLICATION: (VAR.PAGINGS). 28 (5 SUPPL. 1) (PP S187), 2012. DATE OF PUBLICATION: SEPTEMBER-OCTOBER 2012. THE AUTHORS PRESENTED THEIR EXPERIENCE AND OUTCOMES WITH THE TECHNIQUE (ENDOSCOPIC RADIAL ARTERY HARVEST) OVER 8 YEARS. FROM JULY 2004 TO MAY 2012, 580 PATIENTS UNDERWENT ENDOSCOPIC RADIAL ARTERY HARVEST (ERAH). A REUSABLE ESVH SYSTEM WITH THE ADDITION OF A HARMONIC ULTRASONIC SCALPEL/SHEARS (ETHICON) WAS USED TO FACILITATE THE REMOVAL OF THE RADIAL ARTERY (RA) FOR USE IN THE CABG PATIENTS. REPORTED COMPLICATION INCLUDED BLEEDING (N-8) IN WHICH THE PATIENTS REQUIRED THE ADDITIONAL OF A SECOND PROXIMAL ARM INCISION TO CONTROL THE BLEEDING, NEUROLOGICAL IMPAIRMENTS CONSISTED OF TRANSIENT NUMBNESS OVER THE THENAR EMINENCE, INDEX FINGER AND LATERAL FOREARM (N-?) AND CHRONIC NEURALGIAS (N-3). IN CONCLUSION, ERAH CAN BE EFFECTIVELY AND SAFELY ADOPTED AS A HARVEST TECHNIQUE FOR THE RA FOR CABG. THE RESULTS DEMONSTRATE ERAH PROVIDES ADEQUATE LENGTH CONDUITS IN A TIMELY MANNER THROUGH MUCH SMALLER INCISIONS WITHOUT INTIMAL TRAUMA RESULTING IN LOW RATES OF INFECTION AND NEUROLOGICAL IMPAIRMENT AND A VERY HIGH LEVEL OF PATIENT SATISFACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1228329 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention