BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9485134 · Received December 17, 2019

    Report

    Report Number
    3005075853-2019-24464
    Event Type
    Injury
    Date Received
    December 17, 2019
    Date of Event
    January 1, 2009
    Report Date
    November 21, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2009. 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: EVALUATION OF SUBFASCIAL ENDOSCOPIC PERFORATOR VEIN SURGERY (SEPS) USING HARMONIC SCALPEL IN VARICOSE VEINS: AN OBSERVATIONAL STUDY. AUTHOR/S: ANJAY KUMAR, P.N. AGARWAL, PANKAJ KUMAR GARG. CITATION: INTERNATIONAL JOURNAL OF SURGERY 7 (2009) 253¿256. DOI:10.1016/J.IJSU.2009.04.005. THE OBJECTIVE OF THIS PROSPECTIVE STUDY IS TO EVALUATE ROLE OF SUBFASCIAL ENDOSCOPIC PERFORATOR VEIN SURGERY (SEPS) USING ULTRASONIC SCALPEL IN VARICOSE VEINS. TWENTY-ONE PATIENTS (20 MALES, 1 FEMALE), AGES RANGING FROM 18 TO 65 YEARS (MEAN AGE - 39 YEARS), UNDERWENT SEPS USING ULTRASONIC SCALPEL DURING THE PERIOD OF JANUARY 2007 TO DECEMBER 2008. USING THE HARMONIC SCALPEL (ETHICON-ENDO-SURGERY, INC. US) THE SUBFASCIAL SPACE WAS WIDELY EXPLORED FROM THE MEDIAL BORDER OF THE TIBIA TO THE POSTERIOR MIDLINE AND DOWN TO THE LEVEL OF THE MEDIAL MALLEOLUS. ALL PERFORATORS NOTED WERE DIVIDED WITH THE HARMONIC SCALPEL. ONE PERIOPERATIVE COMPLICATION NOTED IS A CASE OF TRANSIENT SAPHENOUS NERVE NEUROPRAXIA. IN CONCLUSION, THE AUTHORS REPORTED THAT THE USE OF ULTRASONIC SCALPEL FOR PERFORMING SEPS IS TECHNICALLY FEASIBLE, CAUSES LESS TISSUE DAMAGE AND REDUCES THE DURATION OF SURGERY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272204 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other