BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VLOC PRODUCT

    MDR report key: 12163562 · Received July 13, 2021

    Report

    Report Number
    2647580-2021-02333
    Event Type
    Injury
    Date Received
    July 13, 2021
    Date of Event
    November 23, 2020
    Report Date
    July 13, 2021
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: STAGED LAPAROSCOPIC MANAGEMENT OF LOCALLY ADVANCED GASTRIC CANCER WITH OUTLET OBSTRUCTION SOURCE: DOI: 10.1002/JSO.26342, 2021 WILEY PERIODICALS LLC WILEYONLINELIBRARY.COM/JOURNAL/JSO J SURG ONCOL. 2021;123:S8¬S14. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY ANALYZED OUTCOMES OF PATIENTS WHO UNDERWENT DISTAL GASTRECTOMY AFTER LAPAROSCOPIC GASTROJEJUNOSTOMY AND CHEMOTHERAPY BETWEEN OCTOBER 2017 AND JUNE 2019. IN THE FIRST PROCEDURE (LAPAROSCOPIC GASTROJEJUNOSTOMY), THE COMMON OPENING OF THE GASTROJEJUNOSTOMY WAS CLOSED WITH V-LOC. IN THE SECOND PROCEDURE (DISTAL GASTRECTOMY), THE INTRODUCTION ORIFICE FOR THE JEJUNOJEJUNOSTOMY WAS CLOSED WITH V-LOC. THERE WERE 15 PATIENTS IN THE STUDY AND COMPLICATIONS INCLUDED: 2 ANASTOMOTIC BLEEDING, 1 EACH FROM THE INITIAL GASTRO-JEJUNOSTOMY AND THE LAPAROSCOPIC DISTAL GASTRECTOMY AND DUODENAL STUMP LEAKAGE IN THE THE LAPAROSCOPIC DISTAL GASTRECTOMY GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059160 UNKNOWN VLOC PRODUCT SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC GAM US SURGICAL PUERTO RICO UNKNOWN VLOC PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other