BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 22375314 · Received July 1, 2025

    Report

    Report Number
    3005075853-2025-05011
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    November 3, 2017
    Report Date
    July 1, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/1/2025. B3: PUBLICATION YEAR OF 2017. D4: BATCH # UNK. 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 BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF PUBLISHED SCIENTIFIC ARTICLES CAPTURED UNDER CAPA-014204. 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. 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: AS REQUESTED BY ETHICON MEDICAL, FOLLOW-UP SENT TO THE AUTHOR FOR CLARIFICATION ON DEVICE USED THAT CAUSED THE VOCAL CORD PALSY. WHAT WAS THE SPECIFIC DEVICE USED WITH THE PATIENT WHO HAD TEMPORARY/PERMANENT VOCAL CORD PALSY? AS PER ARTICLE ¿THE MEDIAL BORDER OF THE LATERAL LYMPH NODE (LN) (RIGHT LEVEL III) WAS DISSECTED FROM THE INTERNAL JUGULAR VEIN AND THE LATERAL BORDER OF RIGHT LEVEL III WAS DISSECTED FROM THE STERNOCLEIDOMASTOID (SCM) MUSCLE USING A HARMONIC SCALPEL (ETHICON) OR PERMANENT CAUTERY HOOK (NON-ETHICON). 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

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: ROBOTIC-ASSISTED MODIFIED RADICAL NECK DISSECTION USING A BILATERAL AXILLO-BREAST APPROACH (ROBOTIC BABA MRND) FOR PAPILLARY THYROID CARCINOMA WITH LATERAL LYMPH NODE METASTASIS. AUTHORS: HYEONG WON YU1; YOUNG JUN CHAI; SU-JIN KIM; JUNE YOUNG CHOI; KYU EUN LEE CITATION: SURG ENDOSC (2018) 32:2322¿2327; DOI: 10.1007/S00464-017-5927-9. THIS RETROSPECTIVE STUDY DESCRIBES SURGICAL OUTCOMES IN PATIENTS WITH PAPILLARY THYROID CARCINOMA (PTC) AND LYMPH NODE METASTASIS (LNM) IN LATERAL NECK COMPARTMENT WHO UNDERWENT ROBOTIC-ASSISTED MODIFIED RADICAL NECK DISSECTION WITH BABA (ROBOTIC BABA MRND). BETWEEN MARCH 2010 AND JULY 2016, 15 PATIENTS (MALE=1, FEMALE=14; MEAN AGE=37.1 ± 9.3 YEARS; MEAN BMI=22.1 ± 3.3 KG/M^2) WERE INCLUDED IN THE STUDY. DURING THE PROCEDURE, THE MEDIAL BORDER OF THE LATERAL LYMPH NODE (LN) (RIGHT LEVEL III) WAS DISSECTED FROM THE INTERNAL JUGULAR VEIN AND THE LATERAL BORDER OF RIGHT LEVEL III WAS DISSECTED FROM THE STERNOCLEIDOMASTOID (SCM) MUSCLE USING A HARMONIC SCALPEL (ETHICON) OR PERMANENT CAUTERY HOOK. REPORTED COMPLICATIONS INCLUDED TEMPORARY/PERMANENT VOCAL CORD PALSY (N=1). IN CONCLUSION, ROBOTIC BABA MRND COULD BE SAFELY PERFORMED AND MAY BE A GOOD SURGICAL OPTION IN SELECTED PATIENTS WITH PTC AND LATERAL LNM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1431203 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention GENERATOR AND HANDPIECE.