BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EGIA TRI STAPLE

    MDR report key: 14019764 · Received April 6, 2022

    Report

    Report Number
    1219930-2022-01220
    Event Type
    Injury
    Date Received
    April 6, 2022
    Date of Event
    June 15, 2021
    Report Date
    April 6, 2022
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: LINEAR STAPLER ANASTOMOSIS FOR ESOPHAGOGASTROSTOMY IN LAPAROSCOPIC PROXIMAL GASTRECTOMY REDUCE REFUX ESOPHAGITIS SOURCE: LANGENBECK¿S ARCHIVES OF SURGERY (2021) 406:2709¿2716 ACCEPTED: 15 JUNE 2021. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED JANUARY 2013 AND SEPTEMBER 2019, A RETROSPECTIVE STUDY AIMED TO CLARIFY WHICH STAPLER IS BETTER FOR ESOPHAGOGASTRECTOMY WITH LYMPHADENECTOMY IN 84 PATIENTS DIAGNOSED WITH EARLY GASTRIC CANCER IN THE UPPER THIRD OF THE STOMACH AND UNDERWENT LAPAROSCOPIC PROXIMAL GASTRECTOMY (LPG). A CIRCULAR STAPLER (CS) WAS USED IN FORTY FIVE (45) PATIENTS FOR THE CS GROUP AND A 45 MILLIMETER LINEAR STAPLER (LS) WAS USED IN THIRTY NINE (39) PATIENTS FOR THE LS GROUP. POSTOPERATIVE COMPLICATIONS INCLUDED: ANASTOMOTIC LEAKS ON ONE PATIENT FOR BOTH GROUPS, ANASTOMOTIC STENOSIS FOR FIVE (5) PATIENTS ON CS GROUP, 2 IN LS GROUP. REFLUX ESOPHAGITIS: IN CS GROUP GRADE A 2 PATIENTS, GRADE B ONE PATIENT, GRADE C 6 PATIENTS, GRADE D 2 PATIENTS. IN LS GROUP GRADE A 5 PATIENTS, GRADE B ONE PATIENT, GRADE C 1 PATIENT. STENOSIS WAS TREATED WITH ENDOSCOPIC BALLOON EXPANSION. IT WAS NOTED THAT ANASTOMOTIC STENOSIS ALSO SEEMED TO BE DUE TO THE TENSION DURING THE DOCKING OF THE BODY AND THE ANVIL OF THE CIRCULAR STAPLER. OTHER COMPLICATIONS THAT WERE NOT RELATED TO THE DEVICE INCLUDED: PNEUMONIA AND WOUND INFECTION. LINEAR STAPLER ANASTOMOSIS FOR ESOPHAGOGASTROSTOMY IN LAPAROSCOPIC PROXIMAL GASTRECTOMY REDUCE RELFUX ESOPHAGITIS, HIROFUMI SUGITA, SHINICHI SAKURAMOTO, SHUICHIRO OYA, NAOTO FUJIWARA, YUTAKA MIYAWAKI, HIROSHI SATOH, KOJUN OKAMOTO, SHIGEKI YAMAGUCHI, ISAMU KOYAMA, 2021, LANGENBECK'S ARCHIVES OF SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2339509 UNKNOWN EGIA TRI STAPLE STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN EGIA TRI STAPLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention