BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA ULTRA

    MDR report key: 23896177 · Received December 26, 2025

    Report

    Report Number
    2647580-2025-03897
    Event Type
    Malfunction
    Date Received
    December 26, 2025
    Date of Event
    December 1, 2025
    Report Date
    December 26, 2025
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    PMA / PMN Number
    K111825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: 030419, 030419 ENDO GIAII 30 3.5MM DLU X6, (LOT NUMBER: P2C0660) BOX00662V1, BOX APPENDECTOMY KIT 3.5MM BLUE, (LOT NUMBER: 0232393914) 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

    IT WAS REPORTED THAT PRIOR TO USE, AFTER LOADING THE RELOAD ON THE MANUAL HANDLE, THE INSTRUMENT COULD NOT BE OPENED AND WAS BLOCKED. THE DEVICE WAS REPLACED WITH ANOTHER OF THE SAME APPLICATION KIT. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1647460 ENDO GIA ULTRA STAPLE, IMPLANTABLE GDW COVIDIEN EGIAUSTND

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11.