BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 22376715 · Received July 1, 2025

    Report

    Report Number
    3005075853-2025-05052
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    December 3, 2019
    Report Date
    July 1, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). B3: UNKNOWN; CAPTURED AS AWARENESS DATE. DATE SENT: 7/1/2025. D4: BATCH # UNK. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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. THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF PUBLISHED SCIENTIFIC ARTICLES CAPTURED UNDER CAPA-014204. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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 · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: MINIMAL INCISION TECHNIQUE FOR HARVESTING OF THE VASCULAR PEDICLE OF THE RADIAL FOREARM FREE FLAP BY ULTRASONICALLY ACTIVATED SHEARS (HARMONIC SCALPEL). AUTHOR CHUNG-HWAN BAEK, WON-YOUNG LEE, SUNG YONG CHOI, MAN KI CHUNG. CITATION: JOURNAL OF PLASTIC, RECONSTRUCTIVE & AESTHETIC SURGERY (2011) 64, E285EE286. THE AIM OF THIS STUDY IS TO VALIDATE THE USEFULNESS OF HARMONIC SCALPEL (HS) AND ITS POTENTIAL TO IMPROVE THE AESTHETIC OUTCOME OF DONOR SITE WHEN USED TO HARVEST THE VASCULAR PEDICLE OF RADIAL FOREARM FREE FLAP (RFFF) THROUGH A MINIMAL INCISION TECHNIQUE. FROM 2010 TO 2011, A TOTAL OF 10 PATIENTS (N=6 MALES AND N=4 FEMALES) WHO UNDERWENT RECONSTRUCTIVE SURGERY OF INTRAORAL SOFT-TISSUE DEFECTS (SIX TONGUE AND FOUR FLOOR OF MOUTH) WITH RFFF WERE INCLUDED. IN THIS STUDY, THE DISSECTION OF PROXIMAL PEDICLE CAN BE PERFORMED USING HARMONIC SCALPEL (ETHICON) UP TO THE TRANSVERSE INCISION LEVEL. COMPLAINT INCLUDED HEMATOMA FORMATION IN THE PEDICLE HARVEST SITE (N=1). THE SOURCE OF BLEEDING WAS THE PERFORATOR BRANCH TO ADJACENT MUSCLES. THE PATIENT WAS TREATED WITH HEMATOMA EVACUATION AND COMPRESSIVE DRESSING FOR SEVERAL DAYS. IN CONCLUSION, HS IS A SAFE AND USEFUL INSTRUMENT FOR HARVESTING THE VASCULAR PEDICLE OF RFFF WITHIN AN ACCEPTABLE TIME PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1452833 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention