BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTRUMENT, ULTRASONIC SURGICAL

    MDR report key: 24712809 · Received March 30, 2026

    Report

    Report Number
    3005075853-2026-02315
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    September 16, 2025
    Report Date
    March 27, 2026
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) DATE SENT: 3/27/2026 B3: PUBLICATION YEAR OF 2025 D4: BATCH # UNK D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS 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. ATTEMPTS ARE BEING 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. DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. 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

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: FIRAT M. ENDOSCOPIC DEEP PLANE FACELIFT: A CLASSIFIED APPROACH. AESTHET SURG J. 2025 SEP 16;45(10):989-1001. DOI: 10.1093/ASJ/SJAF110. ERRATUM IN: AESTHET SURG J. 2025 OCT 27:SJAF194. DOI: 10.1093/ASJ/SJAF194. PMID: 40576459; PMCID: PMC12548052. THE AIM OF THIS STUDY WAS TO PRESENT A SYSTEMATIC ENDOSCOPIC FACELIFT TECHNIQUE WHICH PROPOSES A 5-GROUP CLASSIFICATION SYSTEM TO GUIDE PATIENT-SPECIFIC SURGICAL PLANNING AND OPTIMIZE AESTHETIC OUTCOMES. A TOTAL OF 393 PATIENTS UNDERWENT ENDOSCOPIC FACELIFT SURGERY PERFORMED BY A SINGLE SURGEON BETWEEN 2020 AND 2024. OF THESE, 372 WERE FEMALE (94.6%) AND 21 WERE MALE (5.4%), WITH A MEAN AGE OF 38.1 YEARS (RANGE, 22-70 YEARS). RESECTION OF DEEP TISSUES IS PERFORMED USING A HARMONIC SCALPEL (ETHICON, RARITAN, NJ). REDUCTION OF THE SUPERFICIAL LOBE OF THE SUBMANDIBULAR GLAND IS DONE WITH THE HARMONIC SCALPEL. REPORTED COMPLICATIONS INCLUDE: HARMONIC SCALPEL (EES) NECK SKIN NECROSIS (N=3) TREATMENT: SERIAL DRESSING CHANGE. COSMETIC CONCERNS (N=19) TREATMENT: REVISION PROCEDURE. PERSISTENT SKIN EXCESS IN THE LOWER FACE AND NECK (N=7) TREATMENT: SECONDARY SURGERY (RELIFTING AND ADDITIONAL SKIN EXCISION(N=5). IN CONCLUSION, THIS VERTICAL VECTOR ENDOSCOPIC FACELIFT TECHNIQUE DEMONSTRATES CONSISTENT AESTHETIC RESULTS WITH LOW COMPLICATION AND REVISION RATES. BY COMBINING A CLASSIFICATION-BASED SURGICAL STRATEGY WITH MINIMALLY INVASIVE ACCESS AND DEEP ANATOMICAL CORRECTION, THIS METHOD OFFERS A REPRODUCIBLE, SAFE, AND NATURAL-APPEARING ALTERNATIVE TO TRADITIONAL FACELIFT APPROACHES. FUTURE STUDIES WILL AIM TO INCORPORATE OBJECTIVE ASSESSMENTS AND PATIENT-REPORTED OUTCOME MEASURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773379 INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention