BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 9370237 · Received November 25, 2019

    Report

    Report Number
    3005075853-2019-23762
    Event Type
    Injury
    Date Received
    November 25, 2019
    Report Date
    October 29, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). EVENT DATE UNK. 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. 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. YES I BELIEVE THAT THE LEAK OCCURRED DUE TO MALFUNCTION OF THE STAPLER.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: MID-TERM FOLLOW-UP AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY IN OBESE ADOLESCENTS CITATION: IMAJ; VOL 16; 2014; 37-41. THE AIM OF THIS PROSPECTIVE STUDY WAS TO PROVE THE SAFETY AND EFFICACY OF LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG) SURGERY IN AN ADOLESCENT POPULATION. LSG WAS PERFORMED USING A 4-5 PORT TECHNIQUE. THE STOMACH WAS LONGITUDINALLY RESECTED ALONGSIDE A 36F BOUGIE WITH MULTIPLE LOADS OF ENDOSCOPIC STAPLERS (ENDO GIA ¿ TYCO, COVIDIEN, OR ECHELON 60 ¿ ETHICON) BETWEEN JANUARY 2006 AND DECEMBER 2011, 32 ADOLESCENT PATIENTS (FEMALE=20, MALE=12; AGE RANGE=14-18 YEARS; MEAN BMI=43.2 KG/M^2, BMI RANGE=35-54 KG/M^2) UNDERWENT LSG. REPORTED COMPLICATION INCLUDED EARLY LEAK (N=?) DIAGNOSED BY A CLINICAL PICTURE OF ACUTE LEFT SHOULDER PAIN AND TACHYCARDIA ON POSTOPERATIVE DAY 5, TREATED BY RESECTION OF THE LEAK SITE IN THE PROXIMAL STAPLER LINE DRAINAGE. IN CONCLUSION, LSG IS FEASIBLE AND SAFE IN MORBIDLY OBESE ADOLESCENTS, ACHIEVING EFFICIENT WEIGHT LOSS AND IMPRESSIVE RESOLUTION OF COMORBIDITIES. FURTHER STUDIES ARE REQUIRED TO EVALUATE THE LONG-TERM RESULTS OF THIS PROCEDURE AS WELL AS ITS PLACE AMONG OTHER BARIATRIC OPTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1162527 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention