BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 9652803 · Received January 31, 2020

    Report

    Report Number
    3005075853-2020-00647
    Event Type
    Injury
    Date Received
    January 31, 2020
    Report Date
    January 3, 2020
    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). PUBLICATION YEAR OF 2015. 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: PLEASE CLARIFY THE FOLLOWING: WHAT WAS THE TOTAL NUMBER OF PATIENTS WHO USED HARMONIC SCALPEL AND HAD COMPLAINTS OF OPERATIVE BLOOD LOSS? WHAT WAS THE TOTAL NUMBER OF PATIENTS WHO USED HARMONIC SCALPEL AND HAD COMPLAINTS OF POSTOPERATIVE BLEEDING? WHAT WAS THE TOTAL NUMBER OF PATIENTS WHO USED HARMONIC SCALPEL AND HAD COMPLAINTS OF CHYLOTHORAX? WHAT WAS THE TOTAL NUMBER OF PATIENTS WHO USED HARMONIC SCALPEL AND HAD COMPLAINTS OF SEPSIS? DOES THE SURGEON BELIEVE ANY OF THESE COMPLAINTS WERE RELATED TO THE HARMONIC DEVICE? IF YES, WHICH COMPLAINTS? WERE THERE ANY MEDICAL OR SURGICAL INTERVENTIONS PERFORMED TO TREAT THESE COMPLICATIONS? NO FURTHER INFORMATION WILL BE PROVIDED, BECAUSE WE CAN¿T GET ANY ADDITIONAL INFORMATION FROM THE CUSTOMER.

    Description of Event or Problem · 1

    TITLE: OPERATIVE OUTCOMES OF THORACOSCOPIC LOBECTOMY FOR NON-SMALL-CELL LUNG CANCER. AUTHOR : SHINYA TANE, WATARU NISHIO, HIROMICHI OKUMA, HIROYUKI OGAWA, DAISUKE HOKKA1, KENTA TANE, YUGO TANAKA, KAZUYA UCHINO, MASAHIRO YOSHIMURA AND YOSHIMASA MANIWA; CITATION: ASIAN CARDIOVASCULAR & THORACIC ANNALS 2015, VOL. 23(8) 950¿957; DOI: 10.1177/0218492315596657. THIS STUDY AIMED TO ANALYZE THE IMPACT OF STANDARDIZED TOTALLY THORACOSCOPIC SURGERY ON PERIOPERATIVE OUTCOMES AND TOLERATION OF ADJUVANT CHEMOTHERAPY. BETWEEN APRIL 2010 AND MARCH 2013, A TOTAL OF 657 PATIENTS (308 IN THORACOSCOPY GROUP AND 349 IN THORACOTOMY GROUP) WERE INCLUDED IN THE STUDY (MEAN AGE OF 68 YEARS, MEAN BMI OF 22.7 KG/M2). DURING THE OPERATION, ELECTRIC CAUTERY AND ENERGY DEVICES SUCH AS THE HARMONIC SCALPEL (ETHICON) WERE USED ACCORDING TO THE INDIVIDUAL SURGEON¿S PREFERENCE TO BREAK UP ALL ADHESIONS BETWEEN THE VISCERAL AND PARIETAL PLEURA ON THE OPERATING SIDE, IF POSSIBLE, TO OBTAIN FULL EXPANSION OF THE RESIDUAL LOBES. COMPLAINT INCLUDED OPERATIVE BLOOD LOSS (N=?) [108 ML IN THORACOSCOPY GROUP AND 244 ML IN THORACOTOMY GROUP], POSTOPERATIVE BLEEDING (N=?), CHYLOTHORAX (N=?), AND SEPSIS (N=?). THE RESULTS OF THIS STUDY PRESENTED THAT TOTALLY THORACOSCOPIC LOBECTOMY IS THE MORE BENEFICIAL SURGICAL APPROACH WITH REGARD TO THE INCIDENCE OF POSTOPERATIVE COMPLICATIONS AND TOLERATION OF ADJUVANT CHEMOTHERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114528 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other