BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NANOKNIFE SYSTEM

    MDR report key: 2683323 · Received July 31, 2012

    Report

    Report Number
    1319211-2012-00081
    Event Type
    Injury
    Date Received
    July 31, 2012
    Date of Event
    February 26, 2009
    Report Date
    March 12, 2009
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE NANOKNIFE SYSTEM INCLUDES PROBES THAT ARE SINGLE USE AND DISPOSABLE. NO COMPONENT OF THE SYSTEM WAS RETURNED TO ANGIODYNAMICS, THEREFORE A DEVICE EVALUATION WAS NOT CONDUCTED IN REGARD TO THIS EVENT. DURING A REVIEW OF QUALITY INSPECTION AND MANUFACTURING DOCUMENTS IT WAS DETERMINED THAT THE DEVICE MET ALL SPECIFICATIONS AND QUALITY REQUIREMENTS. A REVIEW OF THE HARDWARE SERVICE DATABASE FOUND NO SERVICE ORDERS FOR THE GENERATOR AROUND THE TIME OF ISSUE. THE CAUSE OF THE HYPERTENSION COULD NOT BE ASCERTAINED, HOWEVER THE CLINICIAN REPORTING STATEMENT INDICATES IT WAS A RESULT OF PROBE PLACEMENT PUNCTURING THE ADRENAL GLAND. THIS EVENT WILL BE TRENDED AND MONITORED BY ANGIODYNAMICS COMPLAINT HANDLING DEPARTMENT. (B)(4).

    Description of Event or Problem · 1

    A (B)(6) PATIENT UNDERWENT NANOKNIFE TREATMENT FOR RENAL CANCER ON (B)(6) 2009. DURING THE TREATMENT THE PATIENT EXPERIENCED AN ADVERSE EVENT. PATIENT HAD A HYPERTENSIVE EPISODE (200+/140 BP) DUE TO THE NEEDLE PROBE PUNCTURE OF LEFT ADRENAL GLAND. THE PATIENT RECOVERED DURING ANAESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NANOKNIFE SYSTEM LEDC THERMAL ABLATION SYSTEM GEI ANGIODYNAMICS, INC. HVP-01

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other