BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN EEA

    MDR report key: 13859965 · Received March 23, 2022

    Report

    Report Number
    2647580-2022-00936
    Event Type
    Death
    Date Received
    March 23, 2022
    Date of Event
    July 15, 2021
    Report Date
    March 22, 2022
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: EAST MEETS WEST: THE INITIAL RESULTS OF LAPAROSCOPIC GASTRIC CANCER RESECTIONS WITH EASTERN PRINCIPLES IN A SINGLE WESTERN CENTRE ¿ A PROPENSITY SCORE-MATCHED STUDY SOURCE: LANGENBECK¿S ARCHIVES OF SURGERY (2021) 406:2699¿2708 HTTPS://DOI.ORG/10.1007/S00423-021-02283-W RECEIVED: 29 MARCH 2021 / ACCEPTED: 15 JULY 2021 © THE AUTHOR(S), UNDER EXCLUSIVE LICENCE TO SPRINGER-VERLAG GMBH GERMANY, PART OF SPRINGER NATURE 2021. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A STUDY COMPARED OUTCOMES OF PATIENTS WHO UNDERWENT LAPAROSCOPIC AND OPEN GASTRIC CANCER SURGERY WITH LYMPH NODE DISSECTION SINCE 1992. THERE WERE 62 PATIENTS IN THE STUDY WITH 31 PATIENTS IN EACH GROUP. THE RECONSTRUCTION OF THE ESOPHAGO-JEJUNOSTOMY WITH A 25MM CIRCULAR STAPLER DEVICE WAS PERFORMED IN 22 PATIENTS IN THE OPEN GROUP AND 3 PATIENTS IN THE LAPAROSCOPIC GROUP. THERE WAS ONE DEATH WITHIN 30 DAYS DUE TO A SURGICAL COMPLICATION IN THE LAPAROSCOPIC GROUP. NO ADDITIONAL INFORMATION WAS PROVIDED AND IT IS UNKNOWN IF THE DEVICE WAS USED IN THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995213 UNKNOWN EEA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO UNKNOWN EEA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death| R