BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NANOKNIFE SYSTEM

    MDR report key: 3021588 · Received March 15, 2013

    Report

    Report Number
    1319211-2013-00041
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    February 24, 2010
    Report Date
    February 24, 2010
    Manufacturer
    ANGIODYNAMICS
    Product Code
    OAB
    PMA / PMN Number
    K080376
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO INDICATION OF A DEVICE MALFUNCTION OR A PRODUCT PROBLEM. THIS REPORT IS NOT BEING SUBMITTED FOR A PRODUCT PROBLEM BUT RATHER TO REPORT THE PATIENT DEVELOPED A PNEUMOTHORAX DURING THE PROCEDURE. THE CAUSE OF THE PNEUMOTHORAX WAS DUE TO THE CHIBA FNP NEEDLE; WHICH WAS USED AS A NEEDLE PLACEMENT GUIDE. PNEUMOTHORAX IS A KNOWN POTENTIAL ADVERSE EFFECT THAT IS DOCUMENTED WITHIN THE NANOKNIFE USER MANUAL. THE USER MANUAL, WHICH IS SUPPLIED TO THE USER WITH THIS UNIT, PNEUMOTHORAX AS A POTENTIAL ADVERSE EFFECT. THE NANOKNIFE SYSTEM INCLUDES SINGLE USE ELECTRODE PROBES AND GENERATOR. NO COMPONENT OF THE SYSTEM WAS RETURNED TO ANGIODYNANICS, THEREFORE, A DEVICE EVALUATION WAS NOT CONDUCTED IN REGARDS TO THIS EVENT. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. (B)(4).

    Description of Event or Problem · 1

    A (B)(6) FEMALE PRESENTED FOR A NANOKNIFE ABLATION OF A LESION LOCATED IN THE SPLENIC NODULES NEAR THE PANCREAS, STOMACH, KIDNEY AND COLON. THE PATIENT DEVELOPED A PNEUMOTHORAX FROM THE CHIBA FNP NEEDLE; WHICH WAS USED AS A NEEDLE PLACEMENT GUIDE. THE PROCEDURE WAS COMPLETED WITHOUT COMPLETIONS. FOLLOW UP 120 HOURS POST PROCEDURE NOTED THAT THE PATIENT WAS DOING WELL AND SUFFERED NO LASTING HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110275 NANOKNIFE SYSTEM LECD THERMAL ABLATION SYSTEM OAB ANGIODYNAMICS 20300101-GENERATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention