BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NANOKNIFE SYSTEM

    MDR report key: 3881761 · Received May 27, 2014

    Report

    Report Number
    1319211-2014-00069
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    ANGIODYNAMICS
    Product Code
    OAB
    PMA / PMN Number
    K080376
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE DEVICE INVOLVED IN THE INCIDENT IS AVAILABLE TO BE RETURNED TO THE MFR FOR EVALUATION. TO DATE, THE DEVICE HAS YET TO BE RETURNED. ATTEMPTS ARE BEING MADE TO OBTAIN THE DEVICE. AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE SERIAL NUMBER (B)(4). THE REVIEW CONFIRMS THAT THE UNIT MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE RESULTS OF THE UNIT EVALUATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. (B)(4).

    Additional Manufacturer Narrative · 1

    THE IRE GENERATOR (SERIAL NUMBER (B)(4)) RECEIVED FIELD SERVICE BY AN ANGIODYNAMICS' FIELD SERVICE ENGINEER. NO DEFECTS OF THE GENERATOR WERE NOTED DURING INITIAL ASSESSMENT. FUNCTIONAL ASSESSMENT WAS PERFORMED ON THE UNIT. THE UNIT MET ALL ACCEPTANCE CRITERIA. THERE WAS NO REPORT OF HARM OR INJURY TO THE PATIENT DUE TO THE PROCEDURE BEING PROLONGED. THE REPORTED COMPLAINT DESCRIPTION COULD NOT BE CONFIRMED AS THE UNIT FUNCTIONED AS INTENDED DURING TESTING AND NO ERRORS WERE FOUND IN THE LOG FILES. A ROOT CAUSE FOR THE COMPLAINT DESCRIPTION COULD NOT BE DETERMINED AS NO DEFECTS WERE FOUND WITH THE GENERATOR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE SERIAL NUMBER (B)(4). THE REVIEW CONFIRMS THAT THE UNIT MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE USER MANUAL, PROVIDED TO THE USER WITH THE SYSTEM INSTRUCTS THE USER ON HOW TO TROUBLESHOOT WHEN THE GENERATOR FAILS SELF-TESTING AS WELL AS UNIT SHUT DOWN ISSUES. THE CATALOG AND LOT NUMBER OF THE DISPOSABLE PROBE USED DURING THE EVENT WAS NOT REPORTED BY THE USER. 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.

    Description of Event or Problem · 1

    AS REPORTED ON (B)(6) 2014, PT OF UNK GENDER AND AGE PRESENTED FOR A LECD THERMAL ABLATION. DURING THE PROCEDURE, IT WAS REPORTED THE NANOKNIFE UNIT EXPERIENCED A HARDWARE COMMUNICATION ERROR MESSAGE, SHUTTING THE UNIT DOWN. THE UNIT WAS REBOOTED SEVERAL TIMES, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THIS SAME UNIT. HOWEVER DUE TO THE EXTENDED DELAY DURING THE PROCEDURE, THE PT WAS ADMINISTERED ADDITIONAL MEDICATION. IT WAS REPORTED THE PT SUFFERED NO HARM OR INJURY DUE TO THE EVENT. IT WAS REPORTED THE NANOKNIFE SYSTEM IS AVAILABLE FOR RETURN FOR EVALUATION TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310661 NANOKNIFE SYSTEM LECD THERMAL ABLATION SYSTEM OAB ANGIODYNAMICS 20300101

    Patients

    Seq Age Sex Outcome Treatment
    1