BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EMPRINT ANTENNA

    MDR report key: 25332891 · Received May 29, 2026

    Report

    Report Number
    3006451981-2026-00044
    Event Type
    Injury
    Date Received
    May 29, 2026
    Date of Event
    January 19, 2026
    Report Date
    May 29, 2026
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS
    Product Code
    NEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THERMAL ABLATION AND RAPID ON-SITE CYTOLOGY FOR LUNG NODULES¿A ¿ONE-STOP SHOP¿ APPROACH FOR SMALL LESIONS: EXPERIENCE IN 8 PATIENTS. ANDREI B. GORGOS / DAMIEN OLIVIÉ / PHILIPPE STEPHENSON / EDITH FILION / HOUDA BAHIG. JOURNAL OF MEDICAL IMAGING AND RADIATION ONCOLOGY, 2026; 70:317¿321 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 LITERATURE, A RECENT TECHNICAL REPORT DESCRIBES THE OUTCOMES OF PATIENTS TREATED WITH MICROWAVE ABLATION OR CRYOABLATION FOLLOWING RAPID ON-SITE DIAGNOSIS OF LUNG CANCER BETWEEN FEBRUARY 2020 AND OCTOBER 2022. IT WAS NOTED THAT MICROWAVE ABLATION WAS ACCOMPLISHED USING A 14 GAUGE EMPRINT ABLATION NEEDLE. THERE WERE 8 PATIENTS INCLUDED IN THE STUDY. 2 PATIENTS DEVELOPED PNEUMOTHORAX WITH ONE OF THEM REQUIRING A DRAINAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306826 UNKNOWN EMPRINT ANTENNA SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY COVIDIEN MEDICAL PRODUCTS UNKNOWN EMPRINT ANTENNA

    Patients

    Seq Age Sex Outcome Treatment
    1