BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLERO

    MDR report key: 24899265 · Received April 16, 2026

    Report

    Report Number
    1319211-2026-00133
    Event Type
    Malfunction
    Date Received
    April 16, 2026
    Date of Event
    April 1, 2026
    Report Date
    April 16, 2026
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    NEY
    UDI-DI
    H787700106002US0
    PMA / PMN Number
    K162449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR A DEVICE EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE FOR PRODUCT PROBLEM IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. REFERENCE (B)(4).

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 19CM SOLERO APPLICATOR. THE APPLICATOR WAS SUCCESSFULLY TESTED AT 100 WATTS FOR 30 SECONDS. THE PROBE WAS THEN PERCUTANEOUSLY PLACED IN THE PATIENT'S LIVER AND THE FIRST ABLATION WAS COMPLETED AT 140W FOR 6 MINUTES. DURING THE SECOND ABLATION, THE UNIT WAS SET FOR 140 WATTS FOR 6 MINUTES. AFTER APPROXIMATELY 2 MINUTES OF ABLATION, THE WATTAGE DROPPED. NO ERROR CODES DISPLAYED, SO THE PHYSICIAN COMPLETED THE ABLATION. WHEN WITHDRAWING THE APPLICATOR, IT WAS NOTED THE CERAMIC TIP HAD DETACHED. A CT SCAN CONFIRMED THE CERAMIC TIP WAS RETAINED INSIDE OF THE PATIENT. THE PATIENT WILL BE OBSERVED AND MONITORED. THE PATIENT DID NOT EXPERIENCE ANY HARM AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957822 SOLERO MICROWAVE TISSUE ABLATION APPLICATOR NEY ANGIODYNAMICS, INC. 700106002-US 5847341 H787700106002US0

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male