MAUDE Adverse Event Report: ANGIODYNAMICS NANOKNIFE SYSTEM; LOW ENERGY DIRECT CURRENT ABLATION SYSTEM

Model Number 20300101

Device Problems Low Sensing Threshold (2575); Device Sensing Problem (2917)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/26/2023

Event Type  malfunction  

Manufacturer Narrative

The nanoknife generator 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).

Event Description

An angiodynamics territory manager reported an issue with a nanoknife 3.0 generator.Thre was a problem between ivy ecg unit and the nanoknife generator.It was reported that as soon as the treatment began, the ivy lost the signal and the ecg fell down between 0 and 30 bpm while the ecg device of anesthesiologist, remained between 60 & 80 bpm.The procedure was completed despite the issue, however, the procedure was prolonged an additional 40 minutes.

Manufacturer Narrative

The unit was initially evaluated in the field on 04-oct-2023 by a task field service technician.The unit required more testing and was returned on 06-oct-2023 to task service center.The service person brought all the accessories that belong to the nk and ivy, including all the cables the customer used.Functional check: field service for repair.Device had a problem with connection between ivy and nk 3.0.The device failed at the self-test at start up (fase 2 2048).Fault 2048 points at a gomeboard and/or switching board.The gome board was replaced and functional test.Was performed.The device functioned as intended, and also does the ivy.The serviceing center was not able to reproduce the communication problem between the unit and the ivy, so they extended the testing even more.While performing treatment as a test, they tested the patient lead cable to the max by forcing it in any possible position.While doing that, finally the connection between nk and ivy was disturbed and lost, shortly but it was indeed lost.Immediately tried to force the error once again but was not able to reproduce.The patient lead cable is almost surely the problem.They cleaned the connections and put the cable back together.Tested the device non-stop for more than 60 minutes with the same cable and the connection didn't fail.They strongly advised to replace the patient lead cable due to trust issues from the customer in the nano knife.Service passed according to procedure svc-002-s10 rev g.Passed electrical safety test according to procedure svc-027 rev.G.This device meets all acceptance criteria.The reported complaint description is not initially confirmed.The unit was functionally tested during field service and met all acceptance criteria.The unit was returned to the service center for further evaluation and failed the self test for error 2048.The gome board was replaced.The patient lead cable that was used at the end user was returned with the unit this time (previously, the patient lead cable and bnc cable were not returned with the unit for evaluation - reference pr31051).When the lead was moved around, communication was lost between the nk and the ivy, which duplicated the customer complaint.The patient lead cable was advised to be replaced.The root cause for the ecg sync was not able to be definitively determined because the unit functioned as intended, however, the patient lead cable was found to cause the intermittent issue and should be replaced.This is the second reported error of this unit for ecg sync issue (reference pr31051).This is the first time the patient lead cable was suggested to be replaced.The root cause for the self test fails (error 2048) was determined to be caused by a faulty gome board, which was replaced.This is the first reported error of this unit for self test fails (error 2048) message.This is the first time the gome board has been replaced.The most likely root cause of the gome board fault is wear and tear.The unit was tested with the new gome board per svc-002-s10 functional test and electrical safety per svc-027 and met all acceptance criteria.Labeling review: the user manual (nanoknife user manual, 16795933-21), which is supplied to the user with this unit states: (ecg sync): "ecg synchronized status indicator is for pulse timing status listed below: "ecg disabled" if 90 ppm or 240 ppm are selected."ecg synchronized" if ecg synchronization is selected and the signal is synchronized."ecg noisy" if ecg synchronization is selected and signal is too fast."ecg no signal" if ecg synchronization is selected and signal is too slow or not present." and "if ecg synchronization was selected, and the ecg signal is noisy, low, or not present during the procedure, the system will indicate by displaying the "pulse timing" status.Energy delivery will not be allowed to continue until the signal is synchronized or the procedure can be restarted if the user returns to one of the screens that has an active settings button to access the pulse timing control screen, and selects either 90 ppm or 240 ppm.This is explained further in section 5.1.3, information screen: clinical data." and "ecg synchronized when first entering the pulse generation screen (figure 6.3.1), the system requires 3.5 seconds to verify the status of the ecg signal.After the 3.5 seconds and before delivering a test pulse, if the ecg signal is synchronized, the button for deliver test pulse will be active and the run section of the screen will display: click 'deliver test pulse' to start." and "after the 3.5 seconds and before delivering a test pulse, if the ecg signal is slow or not present, the button deliver test pulse will be inactive and the run section of the screen (figure 6.3.2) will display: "external ecg trigger no signal.Please check the connection."" and "troubleshooting for "ecg no signal": verify that ecg cables are firmly connected to buttons.Check the display of the synchronization device[?]is it generating a synchronization signal on each r-wave? toggle different lead combinations on the synchronization device until a satisfactory synchronization signal is found.Relocate ecg buttons on patient and try lead combinations again.Check the cable between the synchronization device and generator.Verify that the patient heart rate is not 17 bpm or less.(self test fails - error 2048): "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 states: (ecg sync)."ecg synchronized status indicator is for pulse timing status listed below: "ecg disabled" if 90 ppm or 240 ppm are selected."ecg synchronized" if ecg synchronization is selected and the signal is synchronized."ecg noisy" if ecg synchronization is selected and signal is too fast."ecg no signal" if ecg synchronization is selected and signal is too slow or not present." and "if ecg synchronization was selected, and the ecg signal is noisy, low, or not present during the procedure, the system will indicate by displaying the "pulse timing" status.Energy delivery will not be allowed to continue until the signal is synchronized or the procedure can be restarted if the user returns to one of the screens that has an active settings button to access the pulse timing control screen, and selects either 90 ppm or 240 ppm.This is explained further in section 5.1.3, information screen: clinical data." and "ecg synchronized when first entering the pulse generation screen (figure 6.3.1), the system requires 3.5 seconds to verify the status of the ecg signal.After the 3.5 seconds and before delivering a test pulse, if the ecg signal is synchronized, the button for deliver test pulse will be active and the run section of the screen will display: click 'deliver test pulse' to start." and "after the 3.5 seconds and before delivering a test pulse, if the ecg signal is slow or not present, the button deliver test pulse will be inactive and the run section of the screen (figure 6.3.2) will display: "external ecg trigger no signal.Please check the connection." and "troubleshooting for "ecg no signal": verify that ecg cables are firmly connected to buttons.Check the display of the synchronization device[?] is it generating a synchronization signal on each r-wave? toggle different lead combinations on the synchronization device until a satisfactory synchronization signal is found.Relocate ecg buttons on patient and try lead combinations again.Check the cable between the synchronization device and generator.Verify that the patient heart rate is not 17 bpm or less.(self test fails - error 2048): "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." 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).

Event Description

Additional information, during unit evaluation, the unit failed the self test and showed error 2048.

• Brand Name: NANOKNIFE SYSTEM
• Type of Device: LOW ENERGY DIRECT CURRENT ABLATION SYSTEM
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 17906647
• MDR Text Key: 325306097
• Report Number: 1319211-2023-00067
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K102329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20300101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 01/03/2024
• Supplement Dates FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1