BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NANOKNIFE SYSTEM

    MDR report key: 3021602 · Received March 15, 2013

    Report

    Report Number
    1319211-2013-00032
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    February 10, 2010
    Report Date
    February 10, 2010
    Manufacturer
    ANGIODYNAMICS
    Product Code
    OAB
    PMA / PMN Number
    K080376
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE NANOKNIFE GENERATOR WAS REPORTED TO HAVE HAD SEVERAL HIGH CURRENT WARNINGS DURING THE ABLATION PROCEDURE THERE WAS NO ALLEGATION OF THE UNIT MALFUNCTIONING. THE USER MANUAL, WHICH IS SUPPLIED TO THE USER WITH THIS UNIT, REFERENCES HIGH CURRENT CONDITIONS AND DESCRIBES ACTIONS FOR THE USER TO TAKE TO IN THE EVENT WARNINGS ARE DISPLAYED. IN THE REPORTED EVENT, THE PHYSICIAN LOWERED INPUT VOLTAGE. THE HIGH CURRENT WARNINGS WERE ATTRIBUTED TO LOW RESISTANCE OF THE TREATED TISSUE. ONCE THE VOLTAGE WAS LOWERED THE CASE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. THE TREATING PHYSICIAN ATTRIBUTED THE INFLAMMATION AND EDEMA PRESENT WITHIN THE LESION TO THE LOW TISSUE RESISTANCE, WHICH IN TURN, CAUSED THE MULTIPLE HIGH ERRORS THROUGHOUT THE PROCEDURE. AS REPORTED, THE TREATING PHYSICIAN WAS SATISFIED WITH THE ABLATION RESULTS, AND THERE IS NO REPORTED HARM OR INJURY TO THE PATIENT. 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. 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 LARGE LESION LOCATED ON THE PATIENT'S SCROTUM IN CLOSE PROXIMITY TO THE PENIS AND URETHRA. PRIOR TO THE NANOKNIFE TREATMENT, THE PATIENT PREVIOUSLY UNDERWENT MULTIPLE RADIATION TREATMENTS IN ADDITION TO CHEMO EMBOLIZATION CAUSING INFLAMMATION AND EDEMA. DURING THE ABLATION HIGH CURRENT WARNINGS WERE NOTED ON THE GENERATOR. THE INPUT VOLTAGE WAS LOWERED AND THE CASE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. THE INFLAMMATION AND EDEMA PRESENT WITHIN THE LESION WAS MOST LIKELY CAUSE OF THE LOW RESISTANCE OF THE TREATED TISSUE. POST ABLATION SCAN NOTED ADDITIONAL EDEMA "FORM" THE LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110817 NANOKNIFE SYSTEM LECD THERMAL ABLATION SYSTEM OAB ANGIODYNAMICS 20300101-GENERATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other