BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 16961122 · Received May 19, 2023

    Report

    Report Number
    3005075853-2023-03381
    Event Type
    Injury
    Date Received
    May 19, 2023
    Date of Event
    March 25, 2022
    Report Date
    May 19, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 5/19/2023. D4: BATCH # UNK. THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY 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. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    TITLE: NON-STENTING TREATMENT VERSUS ENDOSCOPIC STENT PLACEMENT IN STAPLE LINE LEAKS AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY. AUTHORS: ANDREAS KIRIAKOPOULOS, NEFELI KOUNATIDIS, ILIAS MENENAKOS, MARIA KOSTROVA, KONSTANTINOS ZOGRAFOS, EVANGELOS MENENAKOS. CITATION CITE: LANGENBECK'S ARCHIVES OF SURGERY (2022) 407:1863¿1872 HTTPS://DOI.ORG/10.1007/S00423-022-02498-5. THE AIM OF THIS STUDY IS TO PRESENT FOR GASTRIC STAPLE LINE LEAKS AFTER LSG DURING THE LAST 13 YEARS. BETWEEN JANUARY 2007 AND AUGUST 2020, 1371 ELIGIBLE PATIENTS UNDERWENT LSG. AFTER GASTRIC LEAK DETECTION, PATIENTS WERE CLASSIFIED INTO TREATMENT GROUPS A (ENDOSCOPIC STENT PLACEMENT) AND B (NON-STENTING MANAGEMENT). OVERALL HOSPITAL STAY, THE TIME TO COMPLETE GASTRIC LEAK RESOLUTION AND THE INCIDENCE OF FURTHER OPERATIVE MANAGEMENT CONSTITUTED THE MAIN OUTCOME MEASURES. STATISTICAL ANALYSIS INCLUDED DESCRIPTIVE STATISTICS AND LINEAR REGRESSION TESTS AS NEEDED. A TOTAL OF 27 PATIENTS (19 F/8 M, MEDIAN AGE: 44.8 YEARS) WERE INCLUDED IN THIS STUDY. A 38-FR BOOGIE IS THEN PLACED TO TRANSECT THE STOMACH ALONG THE LESSER CURVATURE APPLYING MULTIPLE FIRINGS OF ECHELON COMPACT LINEAR CUTTER, 60 MM (ETHICON ENDO-SURGERY, INC.). REPORTED COMPLICATIONS INCLUDED GASTRIC STAPLE LINE LEAK (N=27) IN CONCLUSION CONSERVATIVE, NON-STENTING TREATMENT OF STAPLE LINE LEAKS AFTER LSG IS FEASIBLE AND IS ASSOCIATED WITH SUPERIOR RESULTS IN TERMS OF HOSPITAL SAY AND LEAK RESOLUTION IN COMPARISON TO ENDOSCOPIC STENTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670561 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention