BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLERO

    MDR report key: 23708323 · Received December 3, 2025

    Report

    Report Number
    1317056-2025-00318
    Event Type
    Malfunction
    Date Received
    December 3, 2025
    Date of Event
    November 5, 2025
    Report Date
    December 21, 2025
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    NEY
    UDI-DI
    H787700106002US0
    PMA / PMN Number
    K162449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF PROBE CERAMIC TIP WAS FRACTURED AND DETACHED WAS CONFIRMED BASED ON PICTURE PROVIDED BY THE CUSTOMER. HOWEVER, NO COMPLAINT SAMPLE WAS RETURNED. WITHOUT RECEIVING PRODUCT FOR EVALUATION A DEFINITIVE ROOT CAUSE FOR THIS EVENT CANNOT BE DETERMINED. POTENTIAL ROOT CAUSE FOR THE TIP DETACHED IS THERMAL EVENT THAT FRACTURED THE CERAMIC TIP. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE INDICATED LOTS FOR ANY DEVIATIONS RELATED TO THE REPORTED FAILURE MODE OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS, I.E. NO NCR ASSOCIATED WITH REPORTED FAILURE MODE. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WHICH IS SUPPLIED WITH THIS DEVICE CONTAINS THE FOLLOWING STATEMENTS: INTENDED USE/INDICATIONS FOR USE: THE SOLERO MICROWAVE TISSUE ABLATION (MTA) SYSTEM AND ACCESSORIES ARE INDICATED FOR THE ABLATION OF SOFT TISSUE* DURING OPEN, LAPAROSCOPIC, OR PERCUTANEOUS PROCEDURES. TESTING THE DEVICE: PRIOR TO PLACING THE DEVICE IN THE TARGET TISSUE FOR ABLATION, PLACE THE TIP OF THE DEVICE (INCLUDING THE BLACK SHADED ZONE OF THE SHAFT) IN A CONTAINER OF STERILE WATER OR SALINE AND ACTIVATE THE DEVICE AT 100 WATTS FOR 10 SECONDS TO ENSURE THAT THE SYSTEM IS FUNCTIONAL. WARNING: DO NOT INITIATE THE PROCEDURE/ANESTHESIA UNTIL THE APPLICATOR HAS BEEN CONNECTED, PRIMED, AND THE GENERATOR STATUS BAR INDICATES "READY". PRECAUTIONS: AVOID PLACING LATERAL FORCES ON THE APPLICATOR TIP DURING PLACEMENT OR REMOVAL. ALWAYS USE THE LOWEST POWER AND SHORTEST TIME NECESSARY TO ACHIEVE THE TARGETED ABLATION. EACH APPLICATOR MAY BE USED TO ABLATE UP TO THREE SEPARATE AREAS OF TARGET TISSUE FOR EACH PATIENT AT THE MAXIMUM POWER AND TIME SETTING. INSPECT THE APPLICATOR AFTER EACH ABLATION. IF THE APPLICATOR APPEARS DAMAGED, UTILIZE ANOTHER APPLICATOR FOR SUBSEQUENT ABLATIONS. WARNING: DO NOT BEND THE APPLICATOR AS THIS MAY IMPAIR THE FUNCTION OF THE COOLING SYSTEM AND MAY DAMAGE THE MICROWAVE FEED LINE INSIDE THE APPLICATOR. WARNING: WHEN USING PERCUTANEOUSLY THE TIP OF THE ANTENNA MAY BE USED TO PUNCTURE THE SKIN AT THE POINT OF INSERTION. USE THE MINIMUM FORCE NECESSARY TO ACHIEVE THIS AND TAKE CARE NOT TO OVER ADVANCE THE APPLICATOR. REFER TO THE SHAFT DEPTH MARKINGS TO MONITOR PLACEMENT DEPTH. TAKE CARE TO NOT BEND THE TIP AS IT MAY CAUSE DAMAGE TO THE DEVICE. OPERATIONAL INSTRUCTIONS: INSPECT ALL DEVICES AND PACKAGING FOR DAMAGE PRIOR TO USE. DO NOT USE ANY DEVICES THAT ARE DAMAGED OR IF THE STERILE BARRIER IS BREACHED. DO NOT USE THE SOLERO GENERATOR IF IT HAS BEEN DROPPED OR DAMAGED. WARNING: AFTER EACH ABLATION INSPECT THE APPLICATOR FOR ANY DAMAGE. IF ANY DAMAGE IS OBSERVED THE APPLICATOR SHOULD BE DISCARDED AND REPLACED WITH A NEW APPLICATOR. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO ADVERSE TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. REFERENCE (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. REFERENCE (B)(4).

    Description of Event or Problem · 0

    A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 19CM SOLERO APPLICATOR. THE APPLICATOR WAS SUCCESSFULLY TESTED AT 100WATTS FOR 10 SECONDS. THE UNIT WAS SET AT 140 WATTS FOR 6 MINUTES WHICH WAS PURCUTAEOUSLY PERFORMED WITH NO ISSUES. THE UNIT WAS THEN SET FOR 140 WATTS FOR 4 MINUTES. DURING THAT ABLATION CYCLE, A TEMPERATURE ERROR DISPLAYED. THE APPLICATOR WAS WITHDRAWN AND IT WAS OBSERVED THE TIP OF THE APPLICATOR HAD DETACHED INSIDE OF THE PATIENT'S LIVER. THE TIP WAS LEFT IN THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A NEW OF THE SAME DEVICE. THE PATIENT AND FAMILY WERE MADE AWARE OF THE SITUATION. IT WAS REPORTED THE PATIENT IS STABLE AND DOING WELL POST SURGERY. ADDITIONAL INFORMATION: THE PHYSICIAN HAS BEEN USING SOLERO PRODUCT FOR OVER FIVE YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2855219 SOLERO MICROWAVE TISSUE ABLATION APPLICATOR NEY ANGIODYNAMICS, INC. 700106002-US 5849644 H787700106002US0

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male