BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 22376125 · Received July 1, 2025

    Report

    Report Number
    3005075853-2025-05040
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    May 25, 2016
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/1/2025. B3: PUBLICATION YEAR OF 2016. 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 MANUFACTURING 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. ATTEMPTS WERE 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: THE ARTICLE STATES THAT ¿DONOR SITE COMPLICATIONS FOR FREE FLAPS WITH HS INCLUDED SEROMA¿ HOW WAS THE SEROMA TREATED? HOW IS THE PATIENT DOING NOW? 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

    TITLE: FREE FLAP ELEVATION TIMES IN HEAD AND NECK RECONSTRUCTION USING THE HARMONIC SCALPEL SHEARS AUTHOR: JOSHUA J. DESERRES, BRITTANY R. BARBER, JEFFREY R. HARRIS, DANIEL A. O¿CONNELL. CITATION: PLAST RECONSTR SURG GLOB OPEN 2016;4: E718; DOI: 10.1097/GOX.0000000000000740. THE OBJECTIVE OF THIS RETROSPECTIVE STUDY IS TO EXAMINE THE EFFICACY OF THE HARMONIC SCALPEL (HS) SHEARS ON FREE FLAP ELEVATION TIME AND COMPLICATION RATES AFTER HNC RECONSTRUCTION COMPARED WITH TRADITIONAL ELECTROCAUTERY. FROM JAN2010 TO APR2013, 215 PATIENTS WITH HNC UNDERWENT SURGICAL ABLATION AND FREE FLAP RECONSTRUCTION USING HARMONIC SCALPEL (N=97; N=68 MALE AND N=32 FEMALE; AVERAGE AGE OF 58 YEARS) OR TRADITIONAL TECHNIQUE OF ELECTROCAUTERY (EC) (N=118; N=63 MALE AND N=37 FEMALE; AVERAGE AGE OF 59.9 YEARS). THE HS SHEARS (HS; ETHICON ENDO-SURGERY, CINCINNATI, OHIO) WAS USED IN HS GROUP FOR FREE FLAP ELEVATION. DONOR SITE COMPLICATIONS FOR FREE FLAPS WITH HS INCLUDED SEROMA (N=8). THE HS IS A RELIABLE, SAFE, AND ALTERNATIVE METHOD OF FREE FLAP ELEVATION IN HNC RECONSTRUCTIVE SURGERY. HOWEVER, IT SHOULD BE NOTED THAT THERE WAS A TREND TOWARD INCREASED DONOR-SITE SEROMAS IN THE HS GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1382212 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 GENERATOR AND HANDPIECE.