BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EEA

    MDR report key: 14666053 · Received June 11, 2022

    Report

    Report Number
    2647580-2022-01962
    Event Type
    Injury
    Date Received
    June 11, 2022
    Date of Event
    August 26, 2021
    Report Date
    June 11, 2022
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE: TITLE: POSTOPERATIVE MORBIDITY AND QUALITY OF LIFE BETWEEN TOTALLY LAPAROSCOPIC TOTAL GASTRECTOMY AND LAPAROSCOPY-ASSISTED TOTAL GASTRECTOMY: A PROPENSITY-SCORE MATCHED ANALYSIS SOURCE: PARK ET AL. BMC CANCER (2021) 21:1016 PARK ET AL. BMC CANCER (2021) 21:1016. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED BETWEEN 2012 AND 2018, TO EVALUATE OUTCOMES OF TOTALLY LAPAROSCOPIC TOTAL GASTRECTOMY (TLTG) COMPARED WITH LAPAROSCOPY-ASSISTED TOTAL GASTRECTOMY (LATG) IN PATIENTS WITH GASTRIC CANCER, IN ALL PATIENTS, A MANUAL LINEAR STAPLER WAS USED TO TRANSECT THE ESOPHAGUS, PERFORM THE SIDE-TO SIDE JEJUNO-JEJUNOSTOMY AND TO CLOSE THE JEJUNAL STUMP. A CIRCULAR 25MM MANUAL STAPLER WAS USED FOR THE ESOPHAGOJEJUNOSTOMY. THERE WERE 223 PATIENTS IN THE TLTG 223 AND 114 PATIENTS IN THE LATG GROUP. POSTOPERATIVE COMPLICATIONS INCLUDED: BLEEDING, ANASTOMOSIS LEAKAGE, FLUID COLLECTION, AND ESOPHAGOJEJUNOSTOMY STENOSIS. BLOOD TRANSFUSIONS WERE ALSO REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24068 UNKNOWN EEA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO UNKNOWN EEA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention