BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCGRATH

    MDR report key: 24644318 · Received March 19, 2026

    Report

    Report Number
    3003120897-2026-00548
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Date of Event
    March 3, 2026
    Report Date
    March 19, 2026
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    CCW
    UDI-DI
    10884521824157
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: 340-000-000, 340-000-000 MCGRATH 3.6V BATTERY 340-000-000, LOT# H25011004. 340-000-000, 340-000-000 MCGRATH 3.6V BATTERY 340-000-000, LOT# H25011004. 340-000-000, 340-000-000 MCGRATH 3.6V BATTERY 340-000-000, LOT# H25011004. 340-000-000, 340-000-000 MCGRATH 3.6V BATTERY 340-000-000, LOT# H25011004. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WITH THE BATTERIES, THE HANDLE WAS ABLE TO TURN ON BUT THERE WAS NO DISPLAY, NOT EVEN THE BATTERY ICON PRIOR TO USE. WHEN THE BATTERIES WERE REPLACED THE ISSUE WAS RESOLVED. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703626 MCGRATH LARYNGOSCOPE, RIGID CCW MEDTRONIC SOFAMOR DANEK USA, INC 340-000-000 H25011004 10884521824157

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown