BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NANOKNIFE SYSTEM

    MDR report key: 3021606 · Received March 15, 2013

    Report

    Report Number
    1319211-2013-00030
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    June 16, 2010
    Report Date
    June 16, 2010
    Manufacturer
    ANGIODYNAMICS
    Product Code
    OAB
    PMA / PMN Number
    K080376
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO INDICATION OF A DEVICE MALFUNCTION OR A PRODUCT PROBLEM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT COMPLICATIONS. THIS REPORT IS NOT BEING SUBMITTED FOR A PRODUCT PROBLEM BUT RATHER TO REPORT THE PATIENT'S COLON APPEARED TO HAVE CONSTRICTED DURING TREATMENT. A REVIEW OF THE LOT HISTORY RECORDS WAS PERFORMED FOR THE PACKAGING AND COMPONENT LOTS OBTAINED THROUGH A SHIP HISTORY REPORT FOR ANY DEVIATIONS. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE NANOKNIFE SYSTEM INCLUDES SINGLE USE ELECTRODE PROBES AND GENERATOR. NO COMPONENT OF THE SYSTEM WAS RETURNED TO ANGIODYNAMICS, THEREFORE, A DEVICE EVALUATION WAS NOT CONDUCTED IN REGARDS TO THIS EVENT. THE USER MANUAL, WHICH IS SUPPLIED TO THE USER WITH THIS UNIT, LISTS DAMAGE TO CRITICAL ANATOMICAL STRUCTURE (NERVE, VESSEL, AND/OR DUCT IS A POTENTIAL ADVERSE EFFECT. 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) MALE PRESENTED FOR A NANOKNIFE ABLATION OF A LESION LOCATED IN THE LEFT RETROPERITONEUM (ANTERIOR TO LATISSIMUS DORSI MUSCLE, LATERAL TO SPINE). THE PROPOSED WAS COMPLETED WITHOUT ISSUE OR COMPLICATIONS. WHEN THE TREATING PHYSICIAN REVIEWED THE POST PROCEDURE CT IMAGES, HE NOTED THAT THE PATIENT'S COLON APPEARED TO HAVE CONSTRICTED DURING TREATMENT. FOLLOW UP INFORMATION PROVIDED NOTED THAT THE PATIENT IS RECOVERING FINE AND DID NOT SUFFER ANY LASTING OR PERMANENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110724 NANOKNIFE SYSTEM LECD THERMAL ABLATION SYSTEM OAB ANGIODYNAMICS 20300101-GENERATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other