MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-05-01 for NANOKNIFE SYSTEM 20300101 manufactured by Angiodynamics.
[107722282]
The nanoknife unit (sn (b)(4)) and the associated accusync (sn (b)(4)) were returned for assessment and service. Both devices were received in good condition. The functional check of the nanoknife unit noted no issues. The unit functioned as intended. The functional check of the accusync noted no issues. The unit functioned as intended. The complaint description by the customer was that ecg synchronization button showed no signal during the case and then it came back again. Functional testing of the returned devices noted no issues with either. A definitive root cause for the event cannot be determined, however the most likely root cause was the ecg cable was faulty. The associated ecg cable was not returned with the units, so testing the units with the cable could not be performed. As a precautionary measure, the nanoknife cables as well as the accusync cables were replaced. The units were tested and meet all acceptance criteria. It was reported the patient suffered no adverse effects due to the event. Nanoknife generator: a review of the service order system for the reported serial number 02870416 noted that there have been no previous repairs, servicing and/or upgrades for this unit associated with ecg sync since the unit was distributed. Accusync: a review of the service order system for the reported serial (b)(4) noted that there have been no previous repairs, servicing and/or upgrades for this unit associated with ecg sync since the unit was distributed. The nanoknife user manual, which is supplied to the user with this unit contains the following statements: "the operating system will automatically begin its start-up process and self-checks. It will run through the following self-checks before the user is able to begin the procedure process: initializing device, checking connections, checking status, checking memory, device setup, testing charge, test delivery", "a screen will display each check's progress until the generator completes the start-up self-test and all checks pass successfully", "if one of the generator's self-tests fails, an error message will be displayed. Figure 4. 2. 3 is an example of an error message. The user must then click ok, which will shut down the generator, so that it can be restarted. If all self-tests are successful, the information screen (see figure 5. 1. 1) then appears next on the lcd display", and "troubleshooting: message: error fpga recognition self-test failed. Check that the red stop button is depressed and reboot the system. Possible reasons: red stop button is depressed. Actions: check the red stop button status indicator (green light). It should be lit. If not, twist the button clockwise slightly and release the button. The red stop button indicator should be on". The accusync user manual, which is supplied to the user with the accusync states that "the accusync 72 is a 3 or 5 lead ecg (electrocardiograph) monitor which detects the r-wave of the ecg signal and generates a signal for output to an external device for precision ecg synchronization (also called r-wave triggering or gating). It consists of an isolation amplifier that obtains the signal from the patient and processes it for display or recording". 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[107722283]
This event is considered reportable as the procedure was prolonged due to the need to reboot the ire (irreversible electroporation) system several times. The patient was reported to have been under anesthesia for a prolonged period greater than 30 minutes due to the event. As reported to angiodynamics on april 04, 2018: during an ire procedure, it was reported that the ekg synchronization button on the display screen was yellow. The message "unable to detect" appeared, and the nanoknife unit would not allow the treating physician to charge the probes in order to proceed with the ablation. It was reported that the accusync (ecg sync device), had a good "r" wave and the pink dots were present with each "r" wave. All the cable connections and ekg leads were checked. The ekg leads on the patient were replaced, and the accusync was rebooted. All attempts of troubleshooting were unsuccessful. The nano knife generator and accusync were both successfully rebooted, at which time, the procedure was able to be proceeded. A few minutes later, the unit displayed high current warnings. The unit then displayed the "red stop" button on the screen. The unit was rebooted again, successfully, and the procedure was able to be completed. The reported nanoknife generator has been returned to the manufacturer for evaluation and repair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319211-2018-00038 |
| MDR Report Key | 7475105 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-05-01 |
| Date of Report | 2018-05-01 |
| Date of Event | 2018-04-04 |
| Date Mfgr Received | 2018-04-04 |
| Date Added to Maude | 2018-05-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LAW RYAN |
| Manufacturer Street | 10 GLENS FALLS TECHNICAL PARK |
| Manufacturer City | GLENS FALLS NY 12801 |
| Manufacturer Country | US |
| Manufacturer Postal | 12801 |
| Manufacturer Phone | 5187424488 |
| Manufacturer G1 | ANGIODYNAMICS |
| Manufacturer Street | 603 QUEENSBURY AVENUE |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NANOKNIFE SYSTEM |
| Generic Name | LOW ENERGY DIRECT CURRENT ABLATION SYSTEM |
| Product Code | OAB |
| Date Received | 2018-05-01 |
| Returned To Mfg | 2018-01-10 |
| Model Number | 20300101 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS |
| Manufacturer Address | 603 QUEENSBURY AVENUE QUEENSBURY NY 12804 US 12804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-01 |