BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 11595634 · Received March 31, 2021

    Report

    Report Number
    1219930-2021-01326
    Event Type
    Injury
    Date Received
    March 31, 2021
    Date of Event
    November 19, 2020
    Report Date
    March 31, 2021
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: DOES CIRCULAR STAPLER SIZE IN SURGICAL MANAGEMENT OF ESOPHAGEAL CANCER AFFECT ANASTOMOTIC LEAK RATE? 4-YEAR EXPERIENCE OF A EUROPEAN HIGH-VOLUME CENTER SOURCE: CANCERS 2020, 12, 3474 NOVEMBER 22, 2020. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE, A STUDY RETROSPECTIVELY ANALYZED WHETHER THE STAPLER DIAMETER HAD AN IMPACT ON POSTOPERATIVE ANASTOMOTIC LEAK RATES FOR PATIENTS UNDERGOING AN IVOR LEWIS ESOPHAGECTOMY FOR ESOPHAGEAL CANCER FROM MAY 2016 TO MAY 2020. A TRI-STAPLER WITH A 45MM VIOLET RELOAD WAS APPLIED FOR THE FIRST BITE OF THE CONSTRUCTION OF THE GASTRIC SLEEVE AND USED AT LEAST TWO ADDITIONAL 60MM VIOLET STAPLING MAGAZINES, CONSTRUCTION OF THE GASTRIC CONDUIT WAS COMPLETED. WITH A TRI-STAPLER AND GOLD 45MM, THE AZYGOZ ARCH WAS DIVIDED. IT WAS STATED THAT EITHER A 25MM OR 22 MM STAPLER HEAD DEPENDED ON THE PATIENT¿S ANATOMY WAS INSERTED AND GUIDED INTO THE ESOPHAGUS. A 25MM OR 28 MM STAPLER WAS INSERTED THROUGH THE MINOR CURVATURE OF THE STOMACH, AND AN ESOPHAGOGASTRIC ANASTOMOSIS WAS MADE, RETRIEVING TWO COMPLETE DONUTS. ANOTHER STAPLER LOAD WAS USED TO STAPLE OFF THE OPEN END OF THE STOMACH. AN ANASTOMOTIC LEAK WAS DETECTED IN A TOTAL OF 78 PATIENTS, 33 IN THE SMALL STAPLER GROUP AND 45 IN LARGE STAPLER GROUP. TO INVESTIGATE HOW MANY PATIENTS WITH AN ANASTOMOTIC LEAK DEVELOPED ORGAN FAILURE. LEAKS WERE CATEGORIZED BY SEVERITY WITH TYPE III LEAKS (18 PATIENTS) REQUIRING SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496299 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