BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN EEA

    MDR report key: 23255833 · Received October 9, 2025

    Report

    Report Number
    2647580-2025-03036
    Event Type
    Death
    Date Received
    October 9, 2025
    Date of Event
    July 15, 2025
    Report Date
    October 9, 2025
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TRIEMSTRA L, DE JONGH C, BRENKMAN HJF, WEUSTEN BLAM, FREUND JE, HILLEGERSBERG RV, RUURDA JP. IMPLEMENTING ROBOT-ASSISTED MINIMALLY I NVASIVE GASTRECTOMY (RAMIG) FOR GASTRIC CANCER IN A EUROPEAN TERTIARY REFERRAL CENTER. EUR J SURG ONCOL. 2025 JUL 16;51(10):110342. DOI: 10.1016/J.EJSO.2025.110342. EPUB AHEAD OF PRINT. PMID: 40780020. D10 CONCOMITANT PRODUCTS: UNKNOWN EEA, UNKNOWN EEA, (LOT # UNKNOWN); UNKNOWN EEA, UNKNOWN EEA, (LOT # UNKNOWN); UNKNOWN-VLOC, UNKNOWN VLOC PRODUCT, (LOT # UNKNOWN); UNKNOWN-VLOC, UNKNOWN VLOC PRODUCT, (LOT # UNKNOWN); UNKNOWN EGIA SU, UNKNOWN ENDO GIA SULU, (LOT # UNKNOWN); UNKNOWN EEA, UNKNOWN EEA, (LOT # UNKNOWN). 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 PROSPECTIVE STUDY COMPARED 111 PATIENTS WHO UNDERWENT MINIMALLY INVASIVE GASTRECTOMY (MIG) WITH 75 PATIENTS WHO UNDERWENT ROBOT-ASSISTED MINIMALLY INVASIVE GASTRECTOMY (RAMIG) BETWEEN 2007 AND 2023. IN THE MIG GROUP AND 31 PATIENTS IN THE RAMIG GROUP, A CIRCULAR STAPLER WITH AN ORAL ANVIL WAS USED TO CREATE THE ESOPHAGOJEJUNOSTOMY. IN THE REMAINING RAMIG PATIENTS, A BARBED SUTURE WAS USED TO PERFORM THE ESOPHAGOJEJUNOSTOMY. THE JEJUNOJEJUNOSTOMY WAS EITHER LINEAR STAPLED OR HANDSEWN WITH ANOTHER KIND OF BARBED SUTURE. THE DUODENAL TRANSECTION WAS PERFORMED USING AN ENDOSCOPIC LINEAR STAPLER. THERE WAS ONE PATIENT DEATH IN A PATIENT WITH AN ESOPHAGOJEJUNOSTOMY LEAK IN THE MIG GROUP DUE TO ASPIRATION PNEUMONIA-INDUCED RESPIRATORY FAILURE AND SEPSIS. THE RESPIRATORY FAILURE WAS NOT RELATED TO THE DEVICE AND THE SEPSIS WAS DEVICE RELATED. AN ADDITIONAL DEATH DUE TO CARDIAC ARREST AFTER PULMONARY EMBOLISM WAS NOT RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2509161 UNKNOWN EEA STAPLE, IMPLANTABLE GDW COVIDIEN UNKNOWN EEA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death SEE H11.