BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN EMPRINT ANTENNA

    MDR report key: 10823664 · Received November 11, 2020

    Report

    Report Number
    1717344-2020-01387
    Event Type
    Death
    Date Received
    November 11, 2020
    Date of Event
    May 3, 2020
    Report Date
    November 11, 2020
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    NEY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: IMPROVEMENT OF THE PRIMARY EFFICACY OF MICROWAVE ABLATION OF MALIGNANT LIVER TUMORS BY USING A ROBOTIC NAVIGATION SYSTEM. SOURCE: RADIOL ONCOL 2020; 54(3): 295-300 ACCEPTED (B)(6) 2020. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE ARTICLE COMPARING THE PRIMARY EFFICACY OF ROBOTIC GUIDED ABLATION OF LIVER MALIGNANCIES WITH THAT OF MANUALLY GUIDED ABLATION. BETWEEN 08/2011 AND 11/2018, 192 PATIENTS WITH 264 LIVER TUMORS UNDERWENT EITHER FREE HAND OR ROBOTIC GUIDED MICROWAVE ABLATIONS WITH EITHER A COMPETITOR'S DEVICE OR THE DEVICE. TREATMENT-RELATED PATIENT DEATH (GRADE V) OCCURRED IN 1 (0.57%) OF THE ROBOTIC-GUIDED PROCEDURES AND 0 (0.00%) OF THE FREEHAND GUIDED PROCEDURES WHERE TWO DAYS POST PROCEDURE THE PATIENT EXPERIENCED SEVERE CHOLANGITIS WHICH PROGRESSED TO LIVER AND KIDNEY FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1289470 UNKNOWN EMPRINT ANTENNA SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY COVIDIEN MFG DC BOULDER UNKNOWN EMPRINT ANTENNA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death