BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    H. S. MEDICAL INC. AMICA MICROWAVE ABLATION PROBE

    MDR report key: 9581196 · Received January 10, 2020

    Report

    Report Number
    MW5092184
    Event Type
    Malfunction
    Date Received
    January 10, 2020
    Date of Event
    January 8, 2020
    Report Date
    January 8, 2020
    Manufacturer
    H. S. HOSPITAL SERVICES S. P. A.
    Product Code
    NEY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MICROWAVE ABLATION OF PT WITH HCC, LIVER, SEG IV 4A, W/ CIRRHOSIS, 1.0 CM LESION WAS ABLATED AT 100 WATTS / 15 MINS. TRACK ABLATION AT 40 W/4 SECONDS. AFTER AMICA 14 GAUGE, 15 CM PROBE WAS REMOVED, DR NOTICED THAT THE DISTAL TIP OF THE PROBE REMAINED AT THE EDGE OF THE TUMOR ABLATION ZONE VERIFIED BY CT. THE POST CT SCAN WITH CONTRAST SHOWED GOOD COVERAGE OF THE LESION. NO ADVERSE EVENTS NOTED FOR THE PT AT THIS TIME. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36788 H. S. MEDICAL INC. AMICA MICROWAVE ABLATION PROBE SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY H. S. HOSPITAL SERVICES S. P. A. APK14150T19V5 37011

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR