BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCEFX

    MDR report key: 21196720 · Received January 21, 2025

    Report

    Report Number
    1717344-2025-00163
    Event Type
    Malfunction
    Date Received
    January 21, 2025
    Date of Event
    December 24, 2024
    Report Date
    January 21, 2025
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    UDI-DI
    10884524002613
    PMA / PMN Number
    K944602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: E7507, E7507 POLYHESIVE II REM RET EL W/CORD (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 REPORTER, DURING TOTAL KNEE REPLACEMENT, THE PATIENT HAD SUFFERED BURNS ON THE SHOULDER AT THE PLATE ATTACHMENT AFTER USING THE GENERATOR EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741533 FORCEFX Electrosurgical, cutting & coagulation & accessories GEI COVIDIEN MFG DC BOULDER FORCEFX 10884524002613

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown