BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCGRATH

    MDR report key: 23499082 · Received November 7, 2025

    Report

    Report Number
    3003120897-2025-00521
    Event Type
    Malfunction
    Date Received
    November 7, 2025
    Date of Event
    November 3, 2025
    Report Date
    April 29, 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
    NL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3 AND H6. H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. A VIDEO WAS ALSO PROVIDED. VISUAL INSPECTION NOTED NO DAMAGES. THE BATTERY WAS INSTALLED IN A TEST HANDLE AND WAS UNABLE TO POWER ON, THERE WAS NO DISPLAY OR LED ACTIVATION. THE BATTERY WAS MEASURED TO BE DEPLETED. IT WAS REPORTED THAT MULTIPLE BATTERIES WITH MULTIPLE HANDLES EXHIBITED SEVERAL ISSUES; INCLUDING FAILURE TO TURN ON, ONCE TURNED ON A BLUE SCREEN APPEARED SHOWING THE BATTERY LIFE, STUCK ON A SERIES OF NUMBERS DISPLAYED ON THE SCREEN, AND UNABLE TO TURN OFF THE DEVICE AS SHOWN FROM THE PHOTO AND VIDEO PROVIDED, DESPITE REPLACING THE BATTERIES. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE WAS TRACED TO A COMPONENT FAILURE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. A SECONDARY REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO POTENTIALLY CONTRIBUTING FACTORS. 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

    D10 CONCOMITANT PRODUCT: 340-000-000, 340-000-000 MCGRATH 3.6V BATTERY 340-000-000, LOT# H24120104. 340-000-000, 340-000-000 MCGRATH 3.6V BATTERY 340-000-000, LOT# H24122104. 340-000-000, 340-000-000 MCGRATH 3.6V BATTERY 340-000-000, LOT # H24071204. 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,H3 AND H6. H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS NOT RETURNED, BUT A PHOTO WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED OF THE RETURNED PHOTO THAT A MONITOR WAS TURNED ON AND HAD A BATTERY ICON DISPLAYED ON THE BOTTOM RIGHT CORNER. IT WAS REPORTED THAT IN AN AMBULANCE SETTING, MULTIPLE BATTERIES WITH MULTIPLE HANDLES EXHIBITED SEVERAL ISSUES; INCLUDING FAILURE TO TURN ON, ONCE TURNED ON A BLUE SCREEN APPEARED SHOWING THE BATTERY LIFE, STUCK ON A SERIES OF NUMBERS DISPLAYED ON THE SCREEN, AND UNABLE TO TURN OFF THE DEVICE AS SHOWN FROM THE PHOTO AND VIDEO PROVIDED, DESPITE REPLACING THE BATTERIES. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. 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, IN AN AMBULANCE SETTING, MULTIPLE BATTERIES EXHIBITED SEVERAL ISSUES INCLUDING FAILURE TO TURN ON AND BLUE SCREENS APPEARING. HANDLES WERE TESTED WITH KNOWN GOOD BATTERIES, BUT IT WAS UNKNOWN IF THE PROBLEM WAS RESOLVED AFTER REPLACEMENT. FOR SOME DEVICES, THE LIGHT-EMITTING DIODE WAS ILLUMINATED ON THE DISPLAY, BUT THE BATTERY ICON WAS NOT SHOWN; FOR OTHERS, THE LED WAS NOT ILLUMINATED. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105342 MCGRATH LARYNGOSCOPE, RIGID CCW MEDTRONIC SOFAMOR DANEK USA, INC 340-000-000 H25051204 10884521824157

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE NOTES ON H11