BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON FLEX 60 POWERED PLUS ENDOPATH STAPLER ARTICULATING ENDOSCOPIC LINEAR CUT

    MDR report key: 8687220 · Received June 11, 2019

    Report

    Report Number
    3005075853-2019-19637
    Event Type
    Injury
    Date Received
    June 11, 2019
    Report Date
    May 15, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICE: 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. 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 DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED IN JOURNAL ARTICLE TITLE: THE TECHNICAL OUTCOMES OF DELTA-SHAPED ANASTOMOSIS IN LAPAROSCOPIC DISTAL GASTRECTOMY: A SINGLE-CENTER SAFETY AND FEASIBILITY STUDY. AUTHORS: NOBUHISA MATSUHASHI, KAZUYA YAMAGUCHI, NAOKI OKUMURA, TOSHIYUKI TANAHASHI, SATOSHI MATSUI, HISASHI IMAI, YOSHIHIRO TANAKA, TAKAO TAKAHASHI, SHINJI OSADA, KAZUHIRO YOSHIDA. CITATION: SURG ENDOSC (2017); 31:1257¿1263. DOI: 10.1007/S00464-016-5103-7. THIS STUDY AIMED TO EVALUATE BOTH THE TECHNICAL FEASIBILITY AND SAFETY OF DELTA-SHAPED ANASTOMOSIS WITH LAPAROSCOPIC DISTAL GASTRECTOMY (LDG) ACCORDING TO THE SHORT-TERM OUTCOMES. THE STUDY GROUP WAS COMPOSED OF 229 GASTRIC CANCER PATIENTS (149 MALE AND 80 FEMALE; MEAN AGE: 64.4 ± 11.2 MEAN BODY MASS INDEX (BMI) 22.2 ± 3.1 KG/M2) WHO UNDERWENT DELTA-SHAPED ANASTOMOSIS WITH LDG AT (B)(6) UNIVERSITY SCHOOL OF MEDICINE FROM DECEMBER 2004 TO DECEMBER 2014. THE CARTRIDGE FORK OF A POWERED ECHELON FLEX 60-MM LINEAR STAPLER (ETHICON) WAS INSERTED INTO THE GASTRIC REMNANT, AND ANOTHER FORK WAS INSERTED INTO THE DUODENAL STUMP. THE STAPLER WAS THEN FIRED TO FORM A FUNCTIONAL END-TO-END GASTRODUODENAL ANASTOMOSIS. REPORTED COMPLICATIONS INCLUDED ANASTOMOTIC STENOSIS (N-3), ANASTOMOTIC LEAKAGE (N-3), ANASTOMOTIC ULCER (N-1), BOWEL OBSTRUCTION (N-1), ABDOMINAL ABSCESS (N-1), AND INFECTION (N-1). IN CONCLUSION, THE AUTHORS FOUND THAT DELTA-SHAPED ANASTOMOSIS WITH LDG FOLLOWED BY MECHANICAL ANASTOMOSIS TO BE A SAFE AND FEASIBLE PROCEDURE THAT WAS ASSOCIATED WITH ADVANTAGES, INCLUDING A SMALL WOUND SIZE, REDUCED INVASIVENESS, AND MORE EFFECTIVE ANASTOMOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483276 ECHELON FLEX 60 POWERED PLUS ENDOPATH STAPLER ARTICULATING ENDOSCOPIC LINEAR CUT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention