BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON 60

    MDR report key: 8697264 · Received June 13, 2019

    Report

    Report Number
    3005075853-2019-19712
    Event Type
    Injury
    Date Received
    June 13, 2019
    Report Date
    May 17, 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). 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE 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: SURGICAL TECHNIQUE: LAPAROSCOPIC GASTRIC SLEEVE RESECTION IN SUPER-OBESE PATIENTS . AUTHOR/S: M. ILIC & S.S. PUTNIK. DOI: 10.1080/08941939.2017.1289284. LAPAROSCOPIC GASTRIC SLEEVE (LGS) RESECTION IN SUPER-OBESE PATIENTS (BMI > 50 KG/M2) IS A CHALLENGING PROCEDURE. THE AUTHORS HAVE DEVELOPED A UNIQUE APPROACH AND TECHNIQUE FOR LGS WITH NO BUTTRESS STAPLING AND WITHOUT OVERSEWING. A TOTAL OF 240 LAPAROSCOPIC GASTRIC SLEEVE RESECTIONS (102 PATIENTS IN THE SUPER-OBESE GROUP; BMI: 58 TO 89; 68.6% MALE PATIENTS) WERE DONE AND INCLUDED IN THE STUDY. IT WAS REPORTED THAT ALL LGS RESECTIONS WERE DONE WITH ECHELON FLEX 60 MM STAPLER DEVICE (ETHICON). REPORTED COMPLICATIONS INCLUDED EARLY POST-OPERATIVE BLEEDING (N-2) WHICH WAS SOLVED IN OPEN PROCEDURE, PORT INFECTION (N-2), AND NEO-FUNDUS (N-1) WHICH WAS RESOLVED AFTER RE-DO LGS. IT WAS REPORTED THAT CLEAR DISSECTION AND PROPER STRETCHING OF AN EMPTY STOMACH BEFORE POSITIONING THE STAPLER DEVICE AND FIRMING PROVIDE THE BEST SUCCESS RATE. FOLLOWING PERIOD OF ALL OPERATED PATIENTS FOR 9 YEARS ARE ADEQUATE TO GIVE POSITIVE CONCLUSION ABOUT THE TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491493 ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention