BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCULIS MICROWAVE

    MDR report key: 2181278 · Received July 21, 2011

    Report

    Report Number
    MW5021487
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 21, 2011
    Manufacturer
    MICROSULIS MED LTD
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CERAMIC TIP OF MICROWAVE MACHINE USED FOR ABLATION BROKE OFF AND REMAINS IMBEDDED IN PT'S LIVER. THE PRODUCT HAD BEEN VOLUNTARILY RECALLED AND WAS NOT PUT BACK IN USE UNTIL (B)(6) 2011 WHEN NEW PROBES WERE MADE AVAILABLE BY THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCULIS MICROWAVE SULIS V GEI MICROSULIS MED LTD NONE
    2 VPMTA PROBE 14CM ACCU2IPMTA APPLIC PROBE NEY MICROSULIS MED LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization