BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 9629261 · Received January 24, 2020

    Report

    Report Number
    3005075853-2020-00547
    Event Type
    Injury
    Date Received
    January 24, 2020
    Report Date
    January 8, 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). DATE OF EVENT: PUBLICATION YEAR OF 2017. 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. NO FURTHER INFORMATION WILL BE PROVIDED, BECAUSE WE CAN¿T GET ANY ADDITIONAL INFORMATION FROM THE CUSTOMER.

    Description of Event or Problem · 1

    TITLE: ULTRASONIC ENERGY DEVICE VERSUS MONOPOLAR ENERGY DEVICE IN LAPAROSCOPIC TRANSABDOMINAL PREPERITONEAL (TAPP) INGUINAL HERNIA REPAIR. AUTHOR/S: SHIMPEI OTSUKA, YUJI KANEOKA, ATSUYUKI MAEDA, YUICHI TAKAYAMA, YASUYUKI FUKAMI, SHUNSUKE ONOE. CITATION: UPDATES SURG (2017) 69:55¿60; DOI: 10.1007/S13304-016-0412-X. THIS RETROSPECTIVE STUDY DESCRIBED THE TRANSABDOMINAL PREPERITONEAL (TAPP) REPAIR PROCEDURE AND REPORT THE RESULTS OF A COMPARATIVE STUDY CONDUCTED TO DETERMINE WHETHER THE ULTRASONIC ENERGY DEVICE IS EVEN NECESSARY. BETWEEN NOVEMBER 2012 AND DECEMBER 2014, 241 PATIENTS UNDERWENT TAPP REPAIR FOR INGUINAL HERNIA IN WHICH THE PATIENTS WERE DIVIDED INTO TWO GROUPS: ULTRASONIC ENERGY DEVICE (U GROUP) (MALE=114, FEMALE=15; AGE RANGE=61.1 ± 1.2 YEARS; BMI RANGE 23.0 ± 0.3 KG/M^2) AND MONOPOLAR ENERGY DEVICE (M GROUP) (MALE=123, FEMALE=17; AGE RANGE=61.9 ± 1.1 YEARS; BMI RANGE 23.2 ± 0.3 KG/M^2). HARMONIC ACE (ETHICON) WAS USED IN THE PROCEDURE. THE PERITONEAL DEFECT WAS THEN CLOSED WITH A CONTINUOUS 3-0 VICRYL SUTURE (ETHICON). REPORTED COMPLICATION INCLUDED SEROMA (N=4) WHICH HAD RESOLVED SPONTANEOUSLY OR WITH A ONE-TIME PUNCTURE; FUNICULITIS (N=1) WHICH RESOLVED WITH ANTIBIOTIC THERAPY. IN CONCLUSION, INCREASED COMPETENCE WITH MONOPOLAR ENERGY DEVICE LEAD TO CONCLUDE THAT THE ULTRASONIC ENERGY DEVICE IS UNNECESSARY FOR SIMPLE TAPP REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91465 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention