BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLERO

    MDR report key: 24505715 · Received March 4, 2026

    Report

    Report Number
    1319211-2026-00042
    Event Type
    Malfunction
    Date Received
    March 4, 2026
    Date of Event
    February 2, 2026
    Report Date
    March 11, 2026
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    NEY
    UDI-DI
    H787700106001US0
    PMA / PMN Number
    K162449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF PROBE CERAMIC TIP WAS FRACTURED AND DETACHED WAS CONFIRMED VIA PICTURE PROVIDED, HOWEVER, NO PROBE COMPLAINT SAMPLE WAS RETURNED. WITHOUT RECEIVING PRODUCT FOR EVALUATION A DEFINITIVE ROOT CAUSE FOR THIS EVENT CANNOT BE DETERMINED. POTENTIAL ROOT CAUSE IS A THERMAL EVENT DURING THE ABLATION CYCLE. 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. (B)(4).

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 14CM SOLERO APPLICATOR. PRIOR TO PERCUTANEOUS INSERTION, THE APPLICATOR WAS TESTED FOR 10 SECONDS WITH NO REPORTED ISSUES. THE FIRST ABLATION OF THE PATIENT'S LIVER WAS PERFORMED AT 60 W FOR 4 MINUTES, WITHOUT COMPLICATIONS. THE APPLICATOR WAS REMOVED AND INSPECTED PRIOR TO REINSERTION FOR THE SECOND ABLATION. FOR THE SECOND ABLATION, THE UNIT WAS SET FOR 4 MINUTES AT 100 W. AFTER ONE MINUTE OF ABLATING. THE UNIT REPORTED AN ERROR 209. IT WAS CONFIRMED THE SALINE WAS COOLED; HOWEVER, THEY DECIDED TO REPLACE THE SALINE. WHEN THE ABLATION WAS RESTARTED THE UNIT DISPLAYED A "HIGH REFLECTED POWER (HRP)" MESSAGE. THE APPLICATOR WAS REPOSITIONED BUT NOT REMOVED. THE HRP CONTINUED TO DISPLAY, SO THE UNIT WAS UNPLUGGED FOR TWO MINUTES, AND THE PROCEDURE WAS STARTED AGAIN. THE HRP CONTINUED TO DISPLAY, THEREFORE, THE APPLICATOR WAS WITHDRAWN, AT WHICH POINT IT WAS OBSERVED THAT THE CERAMIC TIP HAD DETACHED AND REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS NOT CONTINUED DUE TO THIS EVENT. THE PATIENT DID NOT EXPERIENCE ANY HARM AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921 SOLERO MICROWAVE TISSUE ABLATION APPLICATOR NEY ANGIODYNAMICS, INC. 700106001-US 5849079 H787700106001US0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female