BEUDAMED
    FDA Adverse Event Death Summary report: N

    MWA PERCUTANEOUS ANTENNA 17 CM

    MDR report key: 2943764 · Received January 30, 2013

    Report

    Report Number
    1717344-2013-00054
    Event Type
    Death
    Date Received
    January 30, 2013
    Date of Event
    December 21, 2012
    Report Date
    January 22, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    NEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SITE INDICATED THAT THE INCIDENT SAMPLE WAS DISCARDED. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A (B)(6) MALE PT EXPIRED TWO DAYS AFTER A CT-CONTROLLED PERCUTANEOUS ABLATION OF 4 LIVER METASTASIS AND PARTIAL LIVER RESECTION WHILE UNDER ANESTHESIA. FIVE ABLATIONS WERE CONDUCTED OVER A THREE HOUR PERIOD AND NO ABNORMALITIES WERE OBSERVED. TWO DAYS AFTER THE PROCEDURE, THE PT SUFFERED LIVER FAILURE AND PASSED AWAY. THE SURGEON HAS STATED THAT HE DOES NOT BELIEVE THE DEVICE CONTRIBUTED TO THE REPORTED EVENT, BUT THE CAUSE OF THE TOTAL LIVER FAILURE CANNOT BE DETERMINED. AN AUTOPSY WAS NOT PERFORMED. ADDITIONAL QUESTIONS HAVE BEEN ASKED TO THE ATTENDING SURGEON. THE DEVICES WERE NOT RETAINED AFTER THE PROCEDURE AND WILL NOT BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40119 MWA PERCUTANEOUS ANTENNA 17 CM MICROWAVE ABLATION ACCESSORY NEY COVIDIEN LP 240862X

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death MWA PUMP TUBING, LOT #6117427X