BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 9556135 · Received January 6, 2020

    Report

    Report Number
    3005075853-2020-00019
    Event Type
    Injury
    Date Received
    January 6, 2020
    Date of Event
    January 1, 2016
    Report Date
    December 9, 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 · 0

    (B)(4). DATE SENT: 1/17/2020. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS RECEIVED: NO FURTHER INFORMATION WILL BE PROVIDED, BECAUSE WE CAN¿T GET ANY ADDITIONAL INFORMATION FROM THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2016. 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: MEASURE OF PANCREAS TRANSECTION AND POSTOPERATIVE PANCREATIC FISTULA. AUTHOR/S: SHINICHIRO TAKAHASHI, MD,* NAOTO GOTOHDA, MD, YUICHIRO KATO, MD, AND MASARU KONISHI, MD. CITATION: JOURNAL OF SURGICAL RESEARCH ¿ 15 MAY 2016 (202) 276 ¿ 283. THIS PROSPECTIVE STUDY AIMED TO COMPARE WHETHER PANCREAS TRANSECTION BY ULTRASONICALLY ACTIVATED SHEARS OR THAT BY SCALPEL CONTRIBUTED MORE TO POSTOPERATIVE PANCREATIC FISTULA (POPF) DEVELOPMENT. AMONG THE 171 PATIENTS, 93 PATIENTS WITH SOFT PANCREAS UNDERWENT PANCREATICODUODENECTOMY (PD) WERE INCLUDED IN THE STUDY BETWEEN JANUARY 2010 AND JUNE 2013. THE PATIENTS WERE DIVIDED INTO TWO GROUPS: ULTRASONICALLY ACTIVATED SCALPEL (UAS) GROUP (N=66; MEAN AGE=65 ± 11 YEARS; BMI=22.2 ± 3.2 KG/M^2) AND SCALPEL GROUP (N=27; MEAN AGE=64 ± 13 YEARS; BMI=21. 8 ± 4.0 KG/M^2). DURING THE PROCEDURE, THE HARMONIC FOCUS CURVED SHEARS AND ETHICON G300 GEN 04 ULTRACISION HARMONIC SCALPEL SURGICAL GENERATOR (ETHICON) WERE USED AS THE HANDPIECE AND GENERATOR. THE POWER LEVEL WAS SET AT 3. THE PANCREAS WAS TRANSECTED USING THE UA SHEARS EXCEPT FOR THE MAIN PANCREATIC DUCT (MPD). REPORTED COMPLICATION INCLUDED INTRAOPERATIVE BLOOD LOSS OF 839 ± 748 ML (N=66) WHICH THE PATIENTS HAD TRANSFUSION (N=?); INTRA-ABDOMINAL ABSCESS (N=2); CHOLANGITIS (N=1); BLEEDING FROM ANASTOMOTIC ULCER (N=1). IN CONCLUSION, SCALPEL TRANSECTION WAS LESS ASSOCIATED WITH POPF THAN UAS TRANSECTION IN PATIENTS WHO UNDERWENT PD FOR SOFT PANCREAS. THE METHOD OF PANCREAS TRANSECTION PLAYS AN IMPORTANT ROLE IN THE PREVENTION OF CLINICAL POPF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12635 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GENERATOR AND HANDPIECE.