BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMICA

    MDR report key: 6431418 · Received March 24, 2017

    Report

    Report Number
    6431418
    Event Type
    Malfunction
    Date Received
    March 24, 2017
    Date of Event
    March 1, 2017
    Report Date
    March 2, 2017
    Manufacturer
    H.S HOSPITAL SERVICE S.P.A.
    Product Code
    NEY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MICROWAVE ABLATION OF LIVER PROCEDURE USING AMICA APPARATUS FOR MICROWAVE ABLATION. THE METALLIC TIP (~1CM) OF THE MICROWAVE PROBE BROKE OFF AND REMAINS IN THE PATIENT AT THE SITE OF TUMOR ABLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214613 AMICA SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY H.S HOSPITAL SERVICE S.P.A. 26134

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR