BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTUS PRECISION

    MDR report key: 5500461 · Received March 15, 2016

    Report

    Report Number
    5500461
    Event Type
    Malfunction
    Date Received
    March 15, 2016
    Date of Event
    February 16, 2016
    Report Date
    February 22, 2016
    Manufacturer
    NEUWAVE MEDICAL, INC.
    Product Code
    NEY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TWO PR-15 PROBES UNDER ULTRASOUND GUIDANCE WERE ADVANCED TO THE EDGE OF THE LIVER. ABLATION BEGAN AT 65 W AND AFTER A MINUTE THE TEAM ENCOUNTERED AN ERROR WITH ONE OF THE PROBES. THE TEAM ENSURED THE PROBE WAS IN GOOD POSITION UNDER ULTRASOUND AND ATTEMPTED TO ABLATE. THEY IMMEDIATELY ENCOUNTERED THE ERROR AGAIN. CT WAS PERFORMED WHICH DEMONSTRATED THE TIP OF THE PROBE HAD FRAGMENTED AND THERE WAS AIR OUTSIDE OF THE LIVER. THE PROBE WAS REMOVED AND FOUND TO BE FRACTURED AT THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156909 CERTUS PRECISION SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY NEUWAVE MEDICAL, INC. ML15111744

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR