BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NANOKNIFE SYSTEM

    MDR report key: 3021582 · Received March 15, 2013

    Report

    Report Number
    1319211-2013-00040
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    March 24, 2010
    Report Date
    March 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

    THE CAUSE OF THE PNEUMOTHORAX COULD NOT BE ASCERTAINED. 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 ANGIODYNAMICS, THEREFORE, A DEVICE EVALUATION WAS NOT CONDUCTED IN REGARDS 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. 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 LIVER NEAR THE PORTAL VEIN AND BILE DUCT. DURING THE COURSE OF THE TREATMENT, TREATING PHYSICIAN NOTED THAT THE SINGLE ELECTRODE PROBES MIGRATED DURING THE ABLATION. THE CASE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. A POST SCAN NOTED NO EVIDENCE OF MECHANICAL DAMAGE CAUSED BY THE MIGRATING PROBES. A SMALL PNEUMOTHORAX WAS NOTED AND THE TREATING PHYSICIAN PLACED A CHEST TUBE. FOLLOW UP 17 HOURS POST PROCEDURE NOTED THAT THE PATIENT WAS DOING WELL AND SUFFERED NO LASTING HARM OR INJURY. NO DEFINITE COMPLICATION OF THE PROBE MIGRATIONS ARE APPARENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110274 NANOKNIFE SYSTEM LECD THERMAL ABLATION SYSTEM OAB ANGIODYNAMICS 20300101-GENERATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention