BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 18658948 · Received February 7, 2024

    Report

    Report Number
    3005075853-2024-01080
    Event Type
    Injury
    Date Received
    February 7, 2024
    Date of Event
    January 1, 2023
    Report Date
    February 7, 2024
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4); DATE SENT: 2/7/2024, B3: PUBLICATION YEAR OF 2023, D4: 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. 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: SKIN BURN AT THE ORAL COMMISSURE CAUSED BY HARMONIC SCALPEL DURING SLEEP APNEA SURGERY AUTHOR: BOSEUNG JUNG, ET AL. CITATION: J CLIN OTOLARYNGOL HEAD NECK SURG 2023; 34(4):197-200 IN PATIENTS WITH OBSTRUCTIVE SLEEP APNEA WHO HAVE NOT RESPONDED TO CONTINUOUS POSITIVE AIRWAY PRESSURE, SURGICAL INTERVENTION MAY BE CONSIDERED FOR AREAS WHERE OBSTRUCTION OR STENOSIS HAS BEEN CONFIRMED THROUGH DRUG-INDUCED SLEEP ENDOSCOPY. THE HARMONIC SCALPEL (ETHICON), A DEVICE THAT OPERATES AT A FREQUENCY OF 55,500 HZ TO CUT AND COAGULATE TISSUE, CAN BE USED FOR PROCEDURES SUCH AS EPIGLOTTECTOMY AND TONSILLECTOMY DURING SLEEP APNEA SURGERY. IN THE PRESENT CASE REPORTED HEREIN, THE HARMONIC SCALPEL WAS CAREFULLY MANEUVERED WITHOUT CONTACTING THE SURROUNDING TISSUE, SUCCESSFULLY COMPLETING THE OPERATION. THE REPORTED COMPLICATIONS INCLUDED (N=1) A SECOND-DEGREE BURN AT THE ORAL COMMISSURE, TREATMENT: NOT MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1366660 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other GENERATOR AND HANDPIECE