BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

    MDR report key: 15310055 · Received August 29, 2022

    Report

    Report Number
    3005075853-2022-05624
    Event Type
    Injury
    Date Received
    August 29, 2022
    Date of Event
    April 5, 2018
    Report Date
    August 29, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: (B)(6) 2022. PUBLICATION YEAR OF 2018. 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. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. CONTACT THE REPORTER VIA PHONE ON (B)(6) 2022, NO INFORMATION CAN BE PROVIDED CURRENTLY. ONCE THERE IS ANY UPDATE, WE WILL UPDATE THE INFORMATION. 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: TRANSORAL SURGERY IN LARGE THYROID GLAND USE IN BENIGN TUMORS * AUTHORS: PENG WEN 1 PENG XIAOWEI 1 LI ZAN 1 LI HUI 1 ZHOU XIAO 1 SONG DAJIANG 1 ZHOU BO 1 LV CHUNLIU 1 WU PENG 1 OUYAN 1 CITATION: JOURNAL OF CLINICAL OTORHINOLARYNGOLOGY HEAD AND NECK SURGERY (2018);32(13):972-975. DOI: 10.13201/J.ISSN. 10011781. 2-018. 13. 003 THE AIM OF THIS STUDY IS TO INVESTIGATE THE VALUE AND FEASIBILITY OF TRANSORAL THYROID SURGERY IN THE TREATMENT OF BENIGN THYROID TUMORS. FROM JULY 2016 TO DECEMBER 2017, A TOTAL OF 76 PATIENTS WITH BENIGN THYROID TUMOR WHO MET THE CRITERIA WERE TREATED SURGICALLY. AMONG THEM, 31 CASES (3 MALE AND 28 FEMALE; AGE WAS 34±10 YEARS) WERE TREATED WITH THYROID SURGERY VIA ORAL VESTIBULAR APPROACH (ENDOSCOPE GROUP) USING HARMONIC SCALPEL AND 4-0 ABSORBABLE SUTURE (JOHNSON & JOHNSON VCP771D), AND 45 CASES (9 MALE AND 36 FEMALE; AGE WAS 36±9 YEARS) WERE TREATED WITH TRADITIONAL OPEN SURGERY AT THE SAME TIME. REPORTED COMPLICATIONS INCLUDE TEMPORARY RECURRENT LARYNGEAL NERVE INJURY (N=1) AND RECOVERED AFTER 3 MONTHS. IN CONCLUSION, TRANSORAL THYROID SURGERY IS SAFE AND EFFECTIVE IN THE TREATMENT OF BENIGN THYROID MASSES, AND IS A GOOD CHOICE FOR PATIENTS WITH COSMETIC NEEDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2318842 HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN) ULTRACISION * SURG DEV, SHEARS, ENDOSCOPIC GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other