BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN)

    MDR report key: 7733195 · Received July 30, 2018

    Report

    Report Number
    3005075853-2018-11697
    Event Type
    Injury
    Date Received
    July 30, 2018
    Report Date
    July 3, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ARTICLE ENTITLED: LAPAROSCOPIC ASSISTED DISTAL GASTRECTOMY WITH BILLROTH I RECONSTRUCTION BY USING CIRCULAR STAPLER. AUTHOR : NOBUHIRO TAKIGUCHI, MD, PHD, YOSHIHIRO NABEYA, MD, PHD, ATSUSHI IKEDA, MD, PHD, HIROAKI SODA, MD, PHD, TORU TONOOKA, MD, PHD, ISAMU HOSHINO, TOSHIYA SAKAMOTO, MD, YOUSUKE IWADATE. CITATION: SURG ENDOSC (2018) 32:S323; P693. THIS OBJECTIVE OF THE STUDY WAS TO EVALUATE THE OUTCOMES AND SAFETY OF THE LAPAROSCOPIC ASSISTED DISTAL GASTRECTOMY. TWO HUNDRED PATIENTS WITH EARLY GASTRIC CANCER UNDERWENT LAPAROSCOPIC DISTAL GASTRECTOMY. THE BILLROTH I RECONSTRUCTION WAS PERFORMED WITH CIRCULAR STAPLER (CDH). GASTRODUODENAL ANASTOMOSIS WAS PERFORMED BY CDH STAPLER. POSTOPERATIVELY, COMPLICATIONS INCLUDED ANASTOMOTIC FAILURE (N=2%), PANCREATIC FISTULA (N=1.5%) AND POSTOPERATIVE BLEEDING (N=1%). THE REOPERATION RATE WAS 2%. ABDOMINAL WALL INCISIONAL HERNIA WAS OBSERVED IN 1%. ALTHOUGH THERE IS THE DISADVANTAGE THAT SMALL LAPAROTOMY CAN BE MADE IN THE UPPER ABDOMEN, LAPAROSCOPIC ASSISTED DISTAL GASTRECTOMY WITH BILLROTH I RECONSTRUCTION IN OUR PROCEDURE IS ENOUGH GOOD FROM THE VIEWPOINT OF THE PRECISION OF PROXIMAL MARGIN, AND THE INCIDENCE OF SERIOUS COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574995 ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN) STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention