BEUDAMED
    FDA Adverse Event Death Summary report: N

    NANOKNIFE SYSTEM

    MDR report key: 19744605 · Received July 15, 2024

    Report

    Report Number
    1319211-2024-00057
    Event Type
    Death
    Date Received
    July 15, 2024
    Date of Event
    July 3, 2024
    Report Date
    January 28, 2025
    Manufacturer
    ANGIODYNAMICS
    Product Code
    OAB
    UDI-DI
    H78720300301US0
    PMA / PMN Number
    K183385
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR A DEVICE EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE FOR PRODUCT PROBLEM IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. REFERENCE (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTIONS: D4 MODEL NUMBER. G4 PMA/510(K) NUMBER. REFERENCE (B)(4).

    Additional Manufacturer Narrative · 0

    THE UNIT WAS RETURNED TO ALPHA SOURCE SERVICE CENTER FOR EVALUATION. FUNCTIONAL CHECK: TECHNICIAN'S NOTES: ASSESSMENT PART 1: NOT ABLE TO REPRODUCE THE SELF-TEST ERROR 2048. DEVICE FAILED OPERATIONAL VERIFICATION DUE TO DAMAGED REAR WHEELS. DEVICE PERFORMED CORRECT CURRENT RAMP UP TEST AND EST. LOG FILES HAVE BEEN SENT TO HARDWARE SERVICES FOR FURTHER ANALYSIS. ASSESSMENT PART 2: LOG FILES ARE REVIEWED BY HARDWARE SERVICE. CONCLUSION: FAULTY PCA INTERFACE. REPLACED PCA INTERFACE, CHARGE PCA AND GOME PCA BOARDS. DAMAGED WHEELCOVER AND SIDE PANELS ARE REPLACED. WHILE PERFORMING THE OPERATIONAL VERIFICATION WE SAW VALUES OF PEAKS AND DIPS IN THE CURRENT AND VOLTAGE WHILE PERFORMING RAMP-UP TEST. THESE LOGFILES WITH PEAKS AND DIPS ARE REVIEWED. CONCLUSION: NOT RELATED, PEAKS AND DIPS ARE WITHIN LIMITS. NO FURTHER INVESTIGATION NEEDED. DEVICE WAS TESTED ACCORDING TO SVC-002-S14 REV H. PASSED EST SVC-027 REV H. DEVICE MEETS ALL ACCEPTANCE CRITERIA. THE REPORTED COMPLAINT WAS NOT CONFIRMED FOR SELF-TEST FAIL/ERROR 2048 DURING SERVICE EVALUATION TESTING. DEVICE FAILED OPERATIONAL VERIFICATION DUE TO DAMAGED REAR WHEELS, WHICH WERE REPLACED. THE LOG FILES WERE REVIEWED, AND THE CUSTOMER COMPLAINT OF SELF-TEST FAIL/ERROR 2048 WAS DETERMINED TO BE TO A FAULT WITH THE PCA INTERFACE (WEAR AND TEAR); PCA INTERFACE WAS REPLACED TO ADDRESS THE UNIT MALFUNCTION AND CHARGE PCA AND GOME PCA BOARDS WERE REPLACED AS A PRECAUTION. THE ROOT CAUSE FOR THE HARDWARE/COMMS ERROR WAS ALSO LIKELY DUE TO THE FAULT WITH THE PCA INTERFACE. THE ROOT CAUSE FOR THE FOR THE DAMAGE TO THE REAR WHEELS IS LIKELY DUE TO HANDLING DAMAGE. A REVIEW OF THE DEVICE HISTORY RECORDS (SERVICE ORDER HISTORY) WAS PERFORMED FOR THE REPORTED SERIAL NUMBER (B)(6) FOR ANY DEVIATIONS RELATED TO THE REPORTED FAILURE MODE OF THE COMPLAINT. THE REVIEW CONFIRMED THAT THE UNIT MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATION PRIOR TO DISTRIBUTION, I.E. NO NCR ASSOCIATED WITH REPORTED FAILURE MODE. LABELING REVIEW: THE USER MANUAL (NANOKNIFE USER MANUAL, 16795933-21), WHICH IS SUPPLIED TO THE USER WITH THIS UNIT STATES: (SELF TEST FAILS) "THE NANOKNIFE GENERATOR WILL BEGIN A START-UP SELF-TEST. IT WILL RUN THROUGH A SERIES OF TESTS BEFORE THE USER GAINS ACCESS TO THE NANOKNIFE SOFTWARE. IF ONE OF THE GENERATOR'S SELF-TEST CHECKS FAILS, AN ERROR MESSAGE WILL BE DISPLAYED. FIGURE 4.2.3 IS AN EXAMPLE OF AN ERROR MESSAGE. THE USER MUST THEN CLICK THE PROCEED BUTTON, WHICH WILL SHUT DOWN THE GENERATOR, SO THAT IT CAN BE RESTARTED. THE NANOKNIFE GENERATOR STARTUP SELF-TEST HAS FAILED BECAUSE OF A DAMAGED OR FAULTY COMPONENT. NOTE THE NUMBER LISTED IN PARENTHESIS IN THE TITLE OF THE POPUP. CALL ANGIODYNAMICS HARDWARE SERVICE." LABELING REVIEW: THE USER MANUAL, WHICH IS SUPPLIED TO THE USER WITH THIS UNIT CONTAINS THE FOLLOWING STATEMENTS: "TROUBLESHOOTING: MESSAGE: HARDWARE / COMMUNICATION FAILURE. POSSIBLE REASONS: STOP BUTTON IS DEPRESSED. ACTIONS: CHECK THE GREEN STOP BUTTON INDICATOR. IT SHOULD BE LIT. IF NOT TWIST THE BUTTON CLOCKWISE SLIGHTLY AND RELEASE THE BUTTON. THE STOP BUTTON INDICATOR SHOULD BE ON." DAMAGE: "MAINTENANCE SHOULD BE CARRIED OUT ONLY BY TRAINED PERSONNEL. THE GENERATOR MUST UNDERGO PERIODIC PREVENTATIVE MAINTENANCE AS SPECIFIED IN THE MAINTENANCE AND SERVICE (SECTION 9). AVOID MOVING THE DEVICE WHEN POWERED ON. AVOID JARRING THE EQUIPMENT DURING TRANSPORT. SYSTEM LOCATION: THE GENERATOR MUST BE INSTALLED AND OPERATED IN AN ENVIRONMENT THAT CONFORMS TO THE OPERATING CONDITIONS SPECIFIED IN SECTION 10.4. THE GENERATOR MUST BE INSTALLED ON RIGID SURFACES SUITABLE TO WITHSTAND ITS WEIGHT. MAINTENANCE CALIBRATION REQUIRED EVERY 12 MONTHS BY AN AUTHORIZED SERVICE AGENT." A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO ADVERSE TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. REFERENCE (B)(4).

    Description of Event or Problem · 0

    AN ANGIODYNAMICS TERRITORY MANAGER REPORTED AN ISSUE WITH A NANOKNIFE 3.0 GENERATOR. DURING TREATMENT, WHEN USING THE LAST PAIR OF PROBES, THE UNIT DISPLAYED AND "OUT OF ORDER" MESSAGE, MESSAGE 2048. DUE TO THIS, THE PROCEDURE WAS NOT COMPLETED. IT WAS ALSO REPORTED A HARDWARE/COMMUNICATION ERROR OCCURRED. ADDITIONAL INFORMATION: THE NK WAS BLOCKED DURING THE TREATMENT. AFTER THEY TRY AROUND 10 TIME TO START AGAIN THE NK. THE ERROR 2048 IS STILL ON THE NK. I HAVE CHECK THIS 2 TIMES, ERROR 2048 IS STILL ON THE NK. AFTER PUT THE ECG ON THE ONE NK I BRING, I TRY AGAIN THE "ANGERS" NK. THIS TIME, HE WILL START PROPERLY. I TRY TO CONNECT BACK THE ECG AND IT STILL START PROPERLY. ADDITIONAL INFORMATION PROVIDED JULY 05, 22024: PATIENT HAS EXPIRED. THIS OCCURRED IN THE ICU 24 HOURS AFTER THE PROCEDURE. IT WAS REPORTED BY ONE OF THE DOCTORS THAT THE PATIENT DIED IN THE EARLY MORNING BECAUSE OF ARRHYTHMIA AND LIVER FAILURE. THE CARDIOLOGIST DISAGREED SAYING THE PATIENT DID NOT HAVE ARRHYTHMIA AND ANOTHER DOCTOR CONCLUDED THE PATIENT DIED OF SEPSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722822 NANOKNIFE SYSTEM LOW ENERGY DIRECT CURRENT ABLATION SYSTEM OAB ANGIODYNAMICS 20300301US H78720300301US0

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Death| O