BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NANOKNIFE TISSUE ABLATION SYSTEM

    MDR report key: 3120098 · Received May 14, 2013

    Report

    Report Number
    3120098
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 14, 2013
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    DURING DIAGNOSTIC LAPAROSCOPY THE MACHINE WAS TURNED ON PRIOR TO USE BUT DID NOT BOOT UP PAST ALL NECESSARY PROGRAMS TO RUN PROPERLY. WE TRIED SEVERAL TIMES TO TROUBLESHOOT BUT WITHOUT SUCCESS. A NEW MACHINE WOULD NOT BE AVAILABLE UNTIL LATER IN THE WEEK. THE PATIENT WILL HAVE TO RETURN TO SURGERY TO COMPLETE THE PROCEDURE WHEN THE NEW EQUIPMENT ARRIVES.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212948 NANOKNIFE TISSUE ABLATION SYSTEM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ANGIODYNAMICS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR