BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EEA

    MDR report key: 23247989 · Received October 8, 2025

    Report

    Report Number
    2647580-2025-03029
    Event Type
    Injury
    Date Received
    October 8, 2025
    Date of Event
    July 15, 2025
    Report Date
    October 9, 2025
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: 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); 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3. CORRECTION: H6. ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DOES NOT MEET THE REPORTING REQUIREMENTS IN 21 CFR 803. 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 BARBED SUTURE. THE DUODENAL TRANSECTION WAS PERFORMED USING AN ENDOSCOPIC LINEAR STAPLER. COMPLICATIONS INCLUDE ANASTOMOTIC AND DUODENAL STUMP LEAK. TREATMENT OF ESOPHAGOJEJUNOSTOMY LEAKS INCLUDED ENDOSCOPIC TREATMENT, REOPERATION, OR ANTIBIOTICS. DUODENAL STUMP LEAKS REQUIRED ANTIBIOTICS AND JEJUNOJEJUNOSTOMY LEAKS REQUIRED SURGICAL INTERVENTION. INTENSIVE CARE UNIT ADMISSION AND PROLONGED HOSPITALIZATION WERE REPORTED. OTHER COMPLICATIONS NOT RELATED TO THE DEVICE INCLUDED INTRAOPERATIVE BLEEDING AND ORGAN INJURY, CHYLE LEAK AND PNEUMONIA. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2611281 UNKNOWN EEA STAPLE, IMPLANTABLE GDW COVIDIEN UNKNOWN EEA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H .