BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 9405433 · Received December 3, 2019

    Report

    Report Number
    3005075853-2019-23925
    Event Type
    Injury
    Date Received
    December 3, 2019
    Date of Event
    January 1, 2019
    Report Date
    November 4, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF REPORT: PUBLICATION YEAR OF 2019. 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. 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.

    Description of Event or Problem · 1

    TITLE: NONINTUBATED THORACOSCOPIC SURGERY FOR LUNG TUMOR: SEVEN YEARS¿ EXPERIENCE WITH 1,025 PATIENTS. AUTHOR : WAN-TING HUNG, MD, MING-HUI HUNG, MD, MS, MAN-LING WANG, MD, YA-JUNG CHENG, MD, PHD, HSAO-HSUN HSU, MD, PHD, AND JIN-SHING CHEN, MD, PHD. CITATION: ANN THORAC SURG. 2019; 107: 1607¿12. DOI: HTTPS://DOI.ORG/10.1016/J.ATHORACSUR.2019.01.013. NONINTUBATED THORACOSCOPIC SURGERY FOR LUNG TUMOR IS NOT WIDELY PERFORMED. THIS STUDY ASSESSED THE SAFETY, OUTCOME, AND RISK FACTORS FOR CONVERSION TO TRACHEAL INTUBATION OF NONINTUBATED THORACOSCOPIC SURGERY FOR LUNG TUMOR RESECTION. THE AUTHORS RETROSPECTIVELY REVIEWED THE RECORDS OF 1,025 PATIENTS (AGE RANGE: 11 TO 91 YEARS OLD; 748 FEMALE AND 277 MALE PATIENTS; BMI: 13.7 TO 35.3) WHO UNDERWENT LUNG TUMOR RESECTION BY NON-INTUBATED THORASCOPIC SURGERY FROM AUGUST 2009 TO DECEMBER 2016. DURING THE THORASCOPIC SURGERY TECHNIQUE, A 30-DEGREE 10-MM OR 5-MM THORACOSCOPE WAS INTRODUCED THROUGH THE PORT. FOR LOBECTOMY AND SEGMENTECTOMY, HILAR DISSECTION WAS ACCOMPLISHED WITH ELECTROCAUTERY OR A HARMONIC SCALPEL (ETHICON), AND PULMONARY VESSELS AND BRONCHI WERE DIVIDED WITH ECHELON FLEX ENDOSTAPLERS (ETHICON). MEDIASTINAL LYMPH NODE DISSECTIONS WERE ACCOMPLISHED USING ELECTROCAUTERY OR A HARMONIC SCALPEL (ETHICON), IF INDICATED. REPORTED COMPLICATIONS INCLUDED BLEEDING DURING THE PROCEDURE (N-6) WHICH REQUIRED CONVERSION TO TRACHEAL INTUBATION IN 4 PATIENTS AND CONVERSION TO THORACOTOMY IN 2 PATIENTS, PROLONGED AIR LEAK (N-20), HEMOTHORAX (N-3), POST-OPERATIVE CHYLOTHORAX (N-2). NONINTUBATED THORACOSCOPIC SURGERY WAS A SAFE AND EFFECTIVE TECHNIQUE FOR LUNG TUMOR RESECTION. CLINICIANS SHOULD BE AWARE THAT PATIENTS WITH A BODY MASS INDEX OF 25 KG/M2 OR HIGHER OR WHO REQUIRE PULMONARY ANATOMICAL RESECTION HAVE A HIGHER RISK OF CONVERSION TO TRACHEAL INTUBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1195895 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1