BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVECURE

    MDR report key: 3493691 · Received November 22, 2013

    Report

    Report Number
    3493691
    Event Type
    Malfunction
    Date Received
    November 22, 2013
    Date of Event
    October 18, 2013
    Report Date
    November 22, 2013
    Manufacturer
    MEDWAVES, INC
    Product Code
    NEY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH COLON CANCER SCHEDULED FOR MICROWAVE ABLATION OF LESIONS. SUBSEQUENTLY, UNDER CT GUIDANCE, 2 MICROWAVE ABLATION NEEDLES WERE INTRODUCED, ONE IN THE LESION IN SEGMENT 8 AND THE OTHER ONE IN THE LESION IN THE SEGMENT 6. CONTRAST WAS INJECTED TO CONFIRM POSITION OF THE NEEDLE IN GOOD POSITION IN THE TUMORS. HOWEVER, WHEN WE CONNECTED THE NEEDLES TO THE MICROWAVE ABLATION MACHINE, THE MACHINE DID NOT WORK. THE CLINICAL SPECIALIST OF THE MEDWAVE COMPANY WAS HERE ON SITE AND COULD NOT MAKE THE MACHINE WORK. HE DISCUSSED THE CASE WITH HIS ENGINEERS. THE MACHINE HAD BEEN CLEARED THE PRIOR DAY BY THE ENGINEERING DEPARTMENT AT EL CAMINO HOSPITAL. THEREFORE, SINCE HE COULD NOT MAKE THE MACHINE WORK, WE JUST DECIDED TO REMOVE THE NEEDLES. THE NEEDLES WERE THEN REMOVED. POST PROCEDURE CT WAS PERFORMED DEMONSTRATING NO EVIDENCE OF BLEEDING OR HEMATOMA.====================== MANUFACTURER RESPONSE FOR MICROWAVE ABLATION, (BRAND NOT PROVIDED) (PER SITE REPORTER)======================

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608227 AVECURE SYSTEM, ABLATION NEY MEDWAVES, INC MWG 881 *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR