BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 22541192 · Received July 18, 2025

    Report

    Report Number
    1219930-2025-03078
    Event Type
    Injury
    Date Received
    July 18, 2025
    Date of Event
    April 26, 2025
    Report Date
    July 18, 2025
    Manufacturer
    COVIDIEN SURGICAL
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: UNKNOWN EGIA SU, UNKNOWN ENDO GIA SULU (LOT#UNKNOWN) MINIMIZING INCISIONAL HERNIA: INTRACORPOREAL ANASTOMOSIS MAKES THE DIFFERENCE AFTER LAPAROSCOPIC RIGHT COLECTOMY: ERNESTO DE GIULIO, INTERNATIONAL JOURNAL OF COLORECTAL DISEASE (2025) 40:112, HTTPS://DOI.ORG/10.1007/S00384-025-04903-Z, PUBLISHED ONLINE: 08 MAY 2025 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY INCLUDING 192 CASES OF LAPAROSCOPIC RIGHT COLECTOMY FOR NEOPLASIA USING EITHER EX TRACORPOREAL ANASTOMOSIS OR INTRACORPOREAL ANASTOMOSIS WERE COMPLETED BETWEEN APRIL 2013 AND JANUARY 2024. TRANSECTION OF THE COLON WAS ACHIEVED USING 60MM STAPLE LOADS ATTACHED TO IDRIVE, SIGNIA, OR A COMPETITOR STAPLER PRODUCT. COMPLICATIONS RESULTING IN EXCLUSION FROM THE STUDY INCLUDED ANASTOMOTIC LEAK. INTERVENTIONS INCLUDED 10 REOPERATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425820 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN SURGICAL UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention