BEUDAMED
    FDA Adverse Event Other Summary report: N

    NANOKNIFE SINGLE ELECTRODE PROBE, 15 CM

    MDR report key: 2211303 · Received May 19, 2011

    Report

    Report Number
    1319211-2011-00041
    Event Type
    Other
    Date Received
    May 19, 2011
    Date of Event
    May 6, 2009
    Report Date
    May 19, 2011
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS NOT BEING SENT FOR A PRODUCT PROBLEM. THERE WAS NO INDICATION THAT THE DEVICE MALFUNCTIONED. THIS REPORT IS BEING SUBMITTED TO NOTIFY THE FDA THAT MEDICAL INTERVENTION WAS REQUIRED POST-PROCEDURE, IN THE FORM OF IV FLUIDS AND MORPHINE TO ALLEVIATE PAIN AND THE PT REQUIRED PROLONGED HOSPITALIZATION OF TWO DAYS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ISSUES. NO PERMANENT HARM OR PERMANENT INJURY WAS REPORTED TO THE PT. THE PT WAS DISCHARGED ON 48 HOURS POST-PROCEDURE AND THE ISSUE IS RESOLVED. THIS MEDWATCH IS BEING SUBMITTED LATE DUE TO A RETROSPECTIVE REVIEW OF CASE NOTES. (B)(4).

    Description of Event or Problem · 1

    AN ULTRASOUND AND CT GUIDED NANOKNIFE ABLATION OF A LIVER LESION WAS SUCCESSFULLY COMPLETED ON (B)(6) 2009. PT EXPERIENCED PAIN POST-PROCEDURE REQUIRING MORPHINE ANALGESIC AND PROLONGED HOSPITALIZATION OF TWO DAYS. IV FLUIDS AND MORPHINE WERE REDUCED AS PT'S PAIN EASED. THE PT WAS DISCHARGED ON (B)(6) 2009. BY (B)(6) 2009, THE ISSUE WAS RESOLVED. NO PERMANENT HARM OR PERMANENT INJURY WAS REPORTED TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NANOKNIFE SINGLE ELECTRODE PROBE, 15 CM TISSUE ABLATION DEVICE GEI ANGIODYNAMICS NA NOR REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| R