BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 8700314 · Received June 14, 2019

    Report

    Report Number
    3005075853-2019-19747
    Event Type
    Injury
    Date Received
    June 14, 2019
    Report Date
    May 22, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). BATCH # UNK. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCE. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS THROUGH A JOURNAL ARTICLE. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED AND IT IS UNKNOWN IF THE EVENTS HAVE BEEN PREVIOUSLY REPORTED. NO CONTACT INFORMATION PROVIDED, THEREFORE, NO FOLLOW UP COULD BE CONDUCTED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN JOURNAL ARTICLE TITLE: BLEEDING AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY: SINGLE BARIATRIC CENTER OF EXCELLENCE EXPERIENCE IN OVER 600 PATIENTS. AUTHOR/S: A. IOSSA, G. GUIDA, M. ABDELGAWAD, F.D. DE ANGELIS, G. SILECCHIA. CITATION: SURG ENDOSC. 2017; 31: S312¿S461. LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG) IS BECOMING THE SECOND MOST PERFORMED BARIATRIC/METABOLIC PROCEDURE IN THE WORLD. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE THE EFFICIENCY OF REINFORCEMENT IN PREVENTION OF POST LSG BLEEDING WITH STANDARDIZATION OF THE TECHNIQUE. FROM JANUARY 2012 TO DECEMBER 2016, PROSPECTIVELY MAINTAINED DATABASE WAS INVESTIGATED ABOUT THE INCIDENCE OF POST-OPERATIVE BLEEDING. A TOTAL OF 671 LSG WERE PERFORMED AND CALIBRATED ON 42 FR BOUGIE USING ECHELON STAPLER-ECHELON FLEX 60 MM STAPLER (ETHICON) WITH CARTRIDGES REINFORCED WITH ABSORBABLE SYNTHETIC BUTTRESS MATERIAL. REPORTED COMPLICATIONS INCLUDED POST-OPERATIVE BLEEDING (N-10) WHICH REQUIRED LAPAROSCOPIC REOPERATION FOR HEMODYNAMIC INSTABILITY IN 6 PATIENTS AND NON-OPERATIVE MANAGEMENT WITH BLOOD TRANSFUSION IN 3 PATIENTS AND CLINICAL MANAGEMENT IN 1 CASE. THE RESULTS CONFIRMED THE EFFECTIVENESS OF BUTTRESS MATERIALS AS REDUCING BLEEDING PRODUCT, WITH AN INCIDENCE RATE SIMILAR TO THESE REPORTED IN LITERATURE. STANDARDIZATION OF THE SURGICAL TECHNIQUE TOGETHER WITH THE USE OF BUTTRESS MAKES LSG, WHICH IS A PROCEDURE WITH HIGH RISK OF BLEEDING FROM THE LONG SUTURE LINE, SAFER WITH LESS BLEEDING RATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493578 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention