BEUDAMED
    FDA Adverse Event Death Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 9663134 · Received February 3, 2020

    Report

    Report Number
    3005075853-2020-00735
    Event Type
    Death
    Date Received
    February 3, 2020
    Report Date
    January 6, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF DEATH UNK. PUBLICATION YEAR OF 2018. 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: IMPACT OF VARIOUS TYPES OF COMORBIDITIES ON THE OUTCOMES OF LAPAROSCOPIC TOTAL GASTRECTOMY IN PATIENTS WITH GASTRIC CARCINOMA. AUTHOR/S: OH JEONG , MI RAN JUNG , SEONG YEOB RYU. CITATION: J GASTRIC CANCER. 2018 SEP;18(3):253-263; HTTPS://DOI.ORG/10.5230/JGC.2018.18.E27. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO INVESTIGATE THE IMPACT OF EACH COMORBIDITY ON THE POSTOPERATIVE COMPLICATIONS OF PATIENTS UNDERGOING LAPAROSCOPIC TOTAL GASTRECTOMY (LTG) FOR GASTRIC CARCINOMA. BETWEEN 2005 AND 2016, A TOTAL OF 303 PATIENTS (N=212 MALES AND N=91 FEMALES, MEAN AGE: 62.1 YEARS, MEAN BMI: 23.6 KG/M2) WHO UNDERWENT LTG FOR MIDDLE- OR UPPER-THIRD GASTRIC CARCINOMA WERE INCLUDED IN THE STUDY. ALL GASTRIC AND LYMPH NODE DISSECTIONS WERE PERFORMED WITH THE USE OF LAPAROSCOPIC ENERGY DEVICES SUCH AS THE HARMONIC SCALPEL (ETHICON) OR LIGASURE. COMPLAINTS INCLUDED ABDOMINAL INFECTION (N=?), ABDOMINAL BLEEDING (N=?), ASCITES (N=?), AND OTHER COMPLICATIONS (N=?). ADDITIONALLY, IT WAS REPORTED THAT THERE WAS ONE PATIENT WHO DIED DUE TO ABDOMINAL INFECTION. IN CONCLUSION, AMONG THE VARIOUS COMORBIDITIES INVESTIGATED, PATIENTS WITH PULMONARY DISEASE HAD A SIGNIFICANTLY HIGHER RISK OF POSTOPERATIVE COMPLICATIONS AFTER LTG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123805 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death GENERATOR AND HANDPIECE