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

Model Number 20300101

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2019

Event Type  Injury  

Manufacturer Narrative

Returned for evaluation was a nanoknife unit, serial number (b)(4).A visual examination of the unit noted the unit was in good physical shape.Functional testing was performed on the unit.The results of the testing are as follows: fired nanoknife at multiple voltages for a range of times and was unable to recreate the issue.Replaced the fpga board as a precautionary measure.Performed operation verification and passed.Performed electrical safety test and passed.Unit meets all acceptance criteria and is ready for use.There was a reported defect/fault.There was no defect noted during unit assessment and functional testing.Unable to duplicate reported defect/fault.The unit functioned as intended during assessment/routine service.The reported complaint of the nanoknife displayed the following error "hardware/communication failure" cannot be confirmed.The nanoknife was fired at multiple voltages for a range of times and was unable to recreate the issue.A root cause for ther reported error message cannot be determined as the no issues were noted during functional testing.A review of the device history records (service order system) was performed for the reported serial number (b)(4) for any deviations related to the reported defect of the complaint.The review confirmed that the unit met all material, assembly, and performance specification prior to distribution.The 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".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.Complaint # (b)(4).

Event Description

A patient of unknown age and gender presented for an ire procedure using the nanoknife system.After the nanoknife probes were placed in the patient via open surgical technique, a test pulse was completed.Upon initiation of the first therapeutic pulse, the nanoknife displayed the following error, "hardware/communication failure pressing the ok button will immediately close the procedure manager application", followed by an "ok box" followed by, "if the red stop button was not pressed, the voltage is still high and the energy delivery may continue if desired, press the red stop button to immediately stop the procedure.The circulating nurse verified that the stop button was not depressed and that the green light near the stop button was illuminated.They then pressed ok and the system rebooted.This happened 3 times.On the 4th time, the machine was able to successfully deliver the pulses.The patient was already under general anesthesia when the error occurred.The delay in the procedure was approximately 45 minutes.This delay meets the criteria of an adverse event due to prolonged exposure to anesthesia (potential patient safety risk).It was reported that the patient suffered no adverse effects due to the event.The customer has returned the nanoknife unit be evaluated by the manufacturer.The unit has been returned to the manufacturer for evaluation.

• Brand Name: NANOKNIFE SYSTEM
• Type of Device: LOW ENERGY DIRECT CURRENT ABLATION SYSTEM,
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: law ryan ; 10 glens falls technical park; glens falls, NY 12801 ; 5187424488
• MDR Report Key: 8692373
• MDR Text Key: 147779032
• Report Number: 1319211-2019-00052
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20300101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Date Manufacturer Received: 05/13/2019
• 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
• Patient Outcome(s): Other