BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 11496557 · Received March 16, 2021

    Report

    Report Number
    1219930-2021-01057
    Event Type
    Injury
    Date Received
    March 16, 2021
    Date of Event
    December 10, 2019
    Report Date
    March 16, 2021
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: T-SHAPED LINEAR-STAPLED CERVICAL ESOPHAGOGASTRIC ANASTOMOSIS FOR MINIMALLY INVASIVE ESOPHAGECTOMY: A PILOT STUDY SOURCE: TUMORI JOURNAL 2020, VOL. 106(6) 506¿509 : 10 DECEMBER 2019. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE, (YEAR MAY 2014 AND DECEMBER 2018) THIS STUDY AIMED TO ASSESS THE OUTCOME OF PATIENTS WHO UNDERWENT TOTAL MINIMALLY INVASIVE ESOPHAGECTOMY (MIE) FOLLOWED BY T-LINEAR-STAPLED CERVICAL ESOPHAGOGASTRIC ANASTOMOSIS. THERE WERE 32 CONSECUTIVE PATIENTS IN THE STUDY AND POST-OPERATIVE COMPLICATIONS INCLUDED MINOR ANASTOMOTIC LEAKAGE IN ONE PATIENT, WHICH WAS HEALED AFTER LOCAL WOUND CARE. IT IS NOTED THAT DURING THE CERVICAL STAGE, ESOPHAGOGASTRIC ANASTOMOSIS WAS OBTAINED WITH THE USE OF AN STAPLER AND THE REMAINING DEFECT OF THE ANASTOMOSIS WAS ALSO CLOSED USING AN STAPLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395374 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention