BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NANOKNIFE SYSTEM

    MDR report key: 3021631 · Received March 15, 2013

    Report

    Report Number
    1319211-2013-00028
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    October 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    ANGIODYNAMICS
    Product Code
    OAB
    PMA / PMN Number
    K080376
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO INDICATION OF A DEVICE MALFUNCTION OR A PRODUCT PROBLEM. THE TREATING PHYSICIAN WAS SATISFIED WITH THE ABLATION WITH NO COMPLICATIONS BEING REPORTED. THE PATIENT WAS TRANSFERRED TO RECOVERY IN GOOD CONDITION. THIS REPORT IS NOT BEING SUBMITTED FOR A PRODUCT PROBLEM BUT RATHER TO REPORT THE CNRA ADMINISTERING THE CONTINUOUS AMOUNTS OF PARALYTIC (ROCURONIUM). 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 SERVICE ORDERS FOR GENERATOR (SN (B)(4)) USED DURING THE CASE NOTED THAT AN OPERATIONAL VERIFICATION (OV) WAS SUCCESSFULLY PERFORMED ON (B)(6) 2010. THE UNIT WAS RETURNED TO THE FIRM (B)(6) 2012 FOR UPGRADE. NO COMPLAINTS WERE NOTED BETWEEN THE OV IN 2010 AND THE UNIT'S RETURN IN 2012. 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

    AS REPORTED (B)(6) 2010, A (B)(6) FEMALE PRESENTED FOR A NANOKNIFE ABLATION OF LIVER LESION LOCATED AT THE PORTAL VEIN BIFURCATION. LATE IN THE CASE, IT WAS DISCOVERED THAT THE CERTIFIED REGISTERED NURSE ANESTHETIST (CNRA) HAD BEEN GIVING THE PATIENT CONTINUOUS DOSES OF PARALYTIC (ROCURONIUM) IN ORDER TO MAINTAIN 0-1 TWITCH RELAXATION THROUGHOUT THE CASE. IT WAS CLARIFIED WITH THE CNA THAT COMPLETE NM RELAXATION IS ONLY NECESSARY DURING PULSE GENERATION. THE PATIENT SUFFERED NO APPARENT SIDE EFFECTS RELATED TO THE CONTINUOUS VS. BOULE NM DOSING. THE TREATING PHYSICIAN WAS SATISFIED WITH THE ABLATION AND NO COMPLICATIONS WERE REPORTED. THE PATIENT WAS TRANSFERRED TO RECOVERY IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110420 NANOKNIFE SYSTEM LECD THERMAL ABLATION SYSTEM OAB ANGIODYNAMICS 20300101-GENERATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other