BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCETRIADZE

    MDR report key: 24244270 · Received February 3, 2026

    Report

    Report Number
    1717344-2026-00167
    Event Type
    Malfunction
    Date Received
    February 3, 2026
    Date of Event
    February 3, 2025
    Report Date
    February 3, 2026
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    UDI-DI
    10884521133310
    PMA / PMN Number
    K110268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: E7507, E7507 POLYHESIVE II REM RET EL W/CORD, E7510-25, E7510-25 POLYHESIVE II PED RET EL X25 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 REPORTER DURING PROCEDURE, THERE WERE BURNS WHILE USING REM (RETURN ELECTRODE MONITORING) PADS. CUT SETTINGS WERE 25/25 CUT AND COAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307845 FORCETRIADZE ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN FORCETRIADZE 10884521133310

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11