BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 22296347 · Received June 20, 2025

    Report

    Report Number
    1219930-2025-02665
    Event Type
    Malfunction
    Date Received
    June 20, 2025
    Date of Event
    March 9, 2025
    Report Date
    June 20, 2025
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: UNKNOWN EGIA SU, UNKNOWN ENDO GIA SULU (LOT#:UNKNOWN) TAKEO FUJITA. "SHORT-AND MIDDLE-TERM OUTCOMES OF ROBOT-ASSISTED MINIMALLY INVASIVE ESOPHAGECTOMY FOR HIGHLY LOCALLY ADVANCED ESOPHAGEAL CANCER WITH STAGE CT3 BORDERLINE AND CT4B AT INITIAL DIAGNOSIS", 2025, HTTPS://DOI.ORG/10.1007/S00464-025-11666-9. 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 81 CASES OF LOCALLY ADVANCED ESOPHAGEAL SQUAMOUS CELL CARCINOMA UNDERGOING EITHER ROBOTIC OR CONVENTIONAL MINIMALLY INVASIVE ESOPHAGECTOMY WITH CURATIVE INTENT WAS COMPLETED BETWEEN 2018 AND 2022. ENDO GIA RADIAL RELOAD WITH TRISTAPLE TECHNOLOGY WAS USED TO CREATE THE GASTRIC CONDUIT. LINEAR ANASTOMOSES WERE ACHIEVED USING 45MM AND 60MM LINEAR ENDO GIA LOADS WITH TRISTAPLE TECHNOLOGY. COMPLICATIONS INCLUDED ANASTOMOTIC LEAKAGE. INTERVENTIONS LISTED INCLUDED COMPUTED TOMOGRAPHY SCANS OR OTHER RADIOLOGICAL IMAGING. OTHER COMPLICATIONS NOT DEVICE RELATED INCLUDE PNEUMONIA, ARRHYTHMIA, AND RECURRENT NERVE PALSY. ADDITIONALLY, IN-HOSPITAL DEATHS OCCURRED IN TWO CASES WITH REASONS UNSPECIFIED. SHORT-AND MIDDLE-TERM OUTCOMES OF ROBOT-ASSISTED MINIMALLY INVASIVE ESOPHAGECTOMY FOR HIGHLY LOCALLY ADVANCED ESOPHAGEAL CANCER WITH STAGE CT3 BORDERLINE AND CT4B AT INITIAL DIAGNOSIS SURGICAL ENDOSCOPY (2025) 39:2994¿3005. HTTPS://DOI.ORG/10.1007/S00464-025-11666-9 TAKEO FUJITA [email protected].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864115 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11.