BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 11292319 · Received February 8, 2021

    Report

    Report Number
    1219930-2021-00513
    Event Type
    Injury
    Date Received
    February 8, 2021
    Date of Event
    August 17, 2020
    Report Date
    February 8, 2021
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: PERFUSION SPEED OF INDOCYANINE GREEN IN THE STOMACH BEFORE TUBULIZATION IS AN OBJECTIVE AND USEFUL PARAMETER TO EVALUATE GASTRIC MICROCIRCULATION DURING IVOR-LEWIS ESOPHAGECTOMY SOURCE: SURGICAL ENDOSCOPY (2020) 34:5649¿5659 PUBLISHED ONLINE: 27 AUGUST 2020. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED FROM MARCH 2017 TO NOVEMBER 2019, WHICH ANALYZED USING INDOCYANINE GREEN (ICG) FLUORESCENCE ANGIOGRAPHY TO DECREASE ANASTOMOTIC LEAK RATE IN 100 PATIENTS WHO UNDERWENT IVOR-LEWIS ESOPHAGECTOMY, AT THE BEGINNING OF THE STUDY, A STAPLED LATERO-LATERAL ANASTOMOSIS WAS PERFORMED WITH THE STAPLER. THERE WERE 7 ANASTOMOTIC LEAKS IN PATIENTS WHO UNDERWENT LATERO-LATERAL ANASTOMOSIS (CLAVIEN¿DINDO II-V). A GASTROGRAFN SWALLOW X-RAY TEST WAS PERFORMED TO ALL PATIENTS BETWEEN POSTOPERATIVE DAY INFORMATION FROM THE UPPER GASTROINTESTINAL ENDOSCOPIES OR REINTERVENTION REPORTS WERE LAPAROSCOPY PLUS CONVERSION TO THORACOTOMY. PATIENTS WITH ANASTOMOTIC LEAK WERE CLASSIFIED INTO THOSE WITH NO MUCOSAL ALTERATIONS AROUND THE ANASTOMOSIS OR THE GASTRIC CONDUIT, THOSE WITH SOME DETERIORATION OR ISCHEMIC LESIONS LARGE MUCOSAL PETECHIAE OR ULCERATION, AND THOSE WITH A CLEAR DESCRIPTION OF FOCAL OR EXTENDED NECROSIS IN CONTACT WITH THE ANASTOMOSIS. ARTICLE: EIDER TALAVERA-URQUIJO; 2020, SPRINGER SCIENCE+BUSINESS MEDIA, LLC, PART OF SPRINGER NATURE 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190106 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention