BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON 60

    MDR report key: 8678722 · Received June 7, 2019

    Report

    Report Number
    3005075853-2019-19529
    Event Type
    Injury
    Date Received
    June 7, 2019
    Report Date
    May 10, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). 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. 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 DEVICES MENTIONED IN THIS ARTICLE CAUSED/CONTRIBUTED TO THE REPORTED EVENTS IN THE ARTICLE?

    Description of Event or Problem · 1

    IT WAS REPORTED IN JOURNAL ARTICLE TITLE: LAPAROSCOPIC SLEEVE GASTRECTOMY: INVESTIGATION OF FUNDUS WALL THICKNESS AND STAPLE HEIGHT¿AN OBSERVATIONAL COHORT STUDY AUTHORS: CLARA BOEKER, JULIAN MALL, CHRISTIAN REETZ, KAMIL YAMAC, LUDWIG WILKENS, CHRISTINE STROH, HINRICH KOEHLER CITATION: OBES SURG. 2017; 27: 3209¿3214. DOI: 10.1007/S11695-017-2755-X. THIS PROSPECTIVE STUDY WAS CARRIED OUT TO INVESTIGATE THE FUNDUS WALL THICKNESS OVER A PERIOD OF 1.5 YEARS. A TOTAL OF 141 PATIENTS (38 MALE AND 103 FEMALE PATIENTS; AGE RANGE: 16 TO 61 YEARS OLD; BMI: 65 TO 76) UNDERGOING LSG, BETWEEN JANUARY 2014 AND JULY 2015 WERE INCLUDED IN THE STUDY. IT WAS REPORTED THAT ALL SURGICAL PROCEDURES WERE PERFORMED USING THE ENDO-CUTTER ECHELON FLEX 60 (ETHICON). AFTER TWO FIRINGS, IT WAS SWITCHED TO STAPLES OF SMALLER HEIGHTS TO FINISH WITH EITHER GOLD OR BLUE STAPLE CARTRIDGES AT THE ANGLE OF HIS. REPORTED COMPLICATIONS INCLUDED STAPLE LINE LEAK (N-3), LATE LEAK AT THE PROXIMAL STAPLE LINE (N-4), INTRAOPERATIVE COMPLICATIONS (N-5), AND SPECIFIC POST-OPERATIVE COMPLICATIONS (INCLUDING LEAKS; N-9). ONLY MALE GENDER CORRELATED WITH HIGHER WALL THICKNESS OF THE FUNDUS. THE FACT THAT ALL THREE PATIENTS WHO DEVELOPED A LEAK WERE FEMALE, AND THE FUNDUS OF FEMALE PATIENTS AS WELL AS THOSE OF THE LEAK GROUP WAS THINNER, INDICATES THAT WALL THICKNESS MAY HAVE AN IMPACT ON THE RATE OF STAPLE LINE LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473959 ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention