BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NANOKNIFE SYSTEM

    MDR report key: 3851225 · Received March 25, 2014

    Report

    Report Number
    1319211-2014-00027
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    February 27, 2014
    Report Date
    February 27, 2014
    Manufacturer
    ANGIODYNAMICS
    Product Code
    OAB
    PMA / PMN Number
    K080376
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 MANUFACTURER 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).

    Description of Event or Problem · 1

    AS REPORTED ON (B)(6) 2014, PATIENT OF UNKNOWN GENDER AND AGE PRESENTED FOR A LECD THERMAL ABLATION OF THE KIDNEY. WHILE PREPPING FOR THE PROCEDURE, IT WAS REPORTED THE NANOKNIFE UNIT FAILED ITS SELF-TEST. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. DUE TO THE DELAY DURING THE PROCEDURE, THE PATIENT WAS ANESTHETIZED FOR GREATER THAN 30 MINUTES. IT WAS REPORTED THE PATIENT SUFFERED NO HARM OR INJURY DUE TO THE EVENT. IT WAS REPORTED THE NANOKNIFE SYSTEM IS AVAILABLE FOR RETURN FOR EVALUATION TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174151 NANOKNIFE SYSTEM LECD THERMAL ABLATION SYSTEM OAB ANGIODYNAMICS 20300101

    Patients

    Seq Age Sex Outcome Treatment
    1