BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 12304941 · Received August 10, 2021

    Report

    Report Number
    3005075853-2021-04619
    Event Type
    Injury
    Date Received
    August 10, 2021
    Date of Event
    August 5, 2019
    Report Date
    July 14, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PUBLICATION YEAR OF 2019, EXACT EVENT DATE UNK. BATCH # UNK. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED.

    Description of Event or Problem · 1

    TITLE: COMPARISON OF THE INTRACORPOREAL TRIANGULAR AND DELTA-SHAPED ANASTOMOTIC TECHNIQUES IN TOTALLY LAPAROSCOPIC DISTAL GASTRECTOMY FOR GASTRIC CANCER: AN ANALYSIS WITH PROPENSITY SCORE MATCHING, AUTHORS: YOSHITOMO YANAGIMOTO, TAKESHI OMORI, YOSHIYUKI FUJIWARA, KOICHI DEMURA, MOON JEONG-HO,NAOKI SHINNO, KAZUYOSHI YAMAMOTO, KEIJIRO SUGIMURA, HIROSHI MIYATA, HAJIME USHIGOME, YUSUKE TAKAHASHI, JUNICHI NISHIMURA, MASAYOSHI YASUI, KEI ASUKAI, DAISAKU YAMADA, HIROSHI WADA,HIDENORI TAKAHASHI, MASAYUKI OHUE, MASAHIKO YANO, MASATO SAKON. CITATION:SURGICAL ENDOSCOPY (2020) 34:2445¿2453, HTTPS://DOI.ORG/10.1007/S00464-019-07025-0. THE OBJECTIVE OF THIS STUDY WAS TO COMPARED THE SHORT-TERM SURGICAL OUTCOMES AND GASTROINTESTINAL FUNCTION BETWEEN INTACT AND DELTA-SA IN TLDG B-I FOR GASTRIC CANCER WITH PROPENSITY SCORE MATCHING (PSM). ACCORDING TO A REVIEW OF PROSPECTIVE GASTRIC CANCER DATABASE, A TOTAL OF 510 GASTRIC CANCER PATIENTS UNDERWENT TLDG B-I, WHICH CONSISTED OF 289 WHO UNDERWENT INTACT AND 221 WHO UNDERWENT DELTA-SA. ONE-TO-ONE PSM YIELDED 177 PAIRS OF INTACT AND DELTA-SA PATIENTS CONSECUTIVE PATIENTS WITH GASTRIC CANCER UNDERWENT GASTRECTOMY FROM JANUARY 2010 TO MAY 2018. AFTER DISTAL GASTRECTOMY, GASTROTOMY WAS PERFORMED ON THE STAPLE LINE ON THE CORNER OF THE GREATER CURVATURE OF THE REMNANT STOMACH. A SMALL HOLE WAS THEN MADE IN THE POSTERIOR TIP OF THE DUODENAL STUMP. THE CARTRIDGE FORK OF A LINEAR STAPLER (ECHELON¿ STAPLER; ETHICON ENDO-SURGERY, CINCINNATI, OH, USA) WAS INSERTED 45 MM INTO THE REMNANT STOMACH. THE STAPLER WAS FIRED TO FORM A SIDE-TO-SIDE GASTRODUODENAL ANASTOMOSIS; A V-SHAPED ANASTOMOSIS WAS CREATED ON THE POSTERIOR WALL. THE ANASTOMOSIS WAS CHECKED TO ENSURE THERE WAS NO BLEEDING OF THE ANASTOMOSIS OR INJURY TO THE MUCOSA VIA THE COMMON STAB INCISION. OUR METHOD OF CLOSING THE COMMON STAB INCISIO OF THE STOMACH AND THE DUODENUM DIFFERED FROM THE ORIGINAL DELTA-SA AND INTACT PROCEDURES. IN VERSION OF INTACT, THREE TEMPORARY SUTURES ARE ADDED TO LOWER END, MIDDLE, AND 2 CM DORSAL TO THE HIGHER END OF THE COMMON STAB INCISION WHEREAS THE COMMON STAB INCISION WAS TEMPORARILY CLOSED WITH A RUNNING SUTURE IN THE ORIGINAL PROCEDURE. DUODENAL CUTTING EDGE AND THE COMMON CLOSED EDGE AT THE SAME TIME USING A 60 MM LINEAR STAPLER (TWO STAPLERS WERE USED IN THE ORIGINAL PROCEDURE). ACCORDINGLY, THE INTERSECTION OF STAPLES MAKES ONE POINT AT THE STOMACH CUTTING EDGE AND COMMON CLOSED EDGE. THE DUODENAL STUMP WITH INSUFFICIENT BLOOD FLOW WAS REMOVED. IN VERSION OF DELTA-SA, THREE TEMPORARY SUTURES ARE ADDED TO EACH END AND THE MIDDLE OF THE COMMON STAB INCISION.THE SUTURES ARE PULLED UP AND THE COMMON STAB INCISION WAS CLOSED WITH A 60 MM STAPLER (TWO STAPLERS WERE USED IN ORIGINAL PROCEDURE), RESULTING IN THE RECONSTRUCTION OF THE INTRACORPOREAL DIGESTIVE TRACT. REPORTED COMPLICATIONS INCLUDED IN DELTA GROUP POSTOPERATIVE LEAKAGE (N=3) IN ALL THREE PATIENTS, POSTOPERATIVE LEAKAGE RESOLVED WITH CONSERVATIVE TREATMENT, CONSISTING OF RADIOLOGICALLY GUIDED DRAIN REPLACEMENT IN TWO PATIENTS AND PLACEMENT OF AN ADDITIONAL PERCUTANEOUS DRAIN IN ONE PATIENT. ANASTOMOTIC BLEEDING (N=1), POSTOPERATIVE ANASTOMOTIC STENOSIS WITHIN 1 YEAR AFTER SURGERY (N=2). IN CONCLUSION INTACT IN TLDG B-I IS SAFE AND FEASIBLE FOR GASTRIC CANCER. GIVEN ITS ACCEPTABLE SURGICAL OUTCOMES, THIS ALTERNATIVE RECONSTRUCTION METHOD CAN BE AN OPTION WITH TLDG B-I.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1198235 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention